HIV
Conditions
Keywords
HIV, Vaccine, FP conjugate, Trimer 4571, Trimer 6931, Adjuplex, Dose escalation
Brief summary
This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.
Detailed description
This study has two parts. Part A will evaluate the safety, tolerability, and immunogenicity of single doses of the FP conjugate, Trimer 4571 and Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Part B. Trimer 4571 with alum adjuvant has been previously evaluated in humans but will be tested in Part A with Adjuplex. Part B will evaluate the safety, tolerability, and immunogenicity of FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, or Trimer 6931, or both alone and then both Trimers combined. Total study duration is 36 months (includes enrollment, planned safety holds and follow-up).
Interventions
BIOLOGICALFP conjugate vaccine (25 mcg)
FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
BIOLOGICALFP conjugate vaccine (200 mcg)
FP8v1-rTTHC (FP conjugate vaccine) is an HIV-1 fusion peptide conjugated to recombinant tetanus toxoid heavy chain fragment C (rTTHC) via sulfo-SIAB chemical linker. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
BIOLOGICALTrimer 6931 (100 mcg)
HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC). Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
BIOLOGICALTrimer 6931 (200 mcg)
HIV-1 Trimer 6931 (Trimer 6931) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from consensus clade C sequence (ConC). Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
BIOLOGICALTrimer 4571 (200 mcg)
HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
BIOLOGICALTrimer 4571 (100 mcg)
HIV-1 Trimer 4571 (Trimer 4571) is a synthetic soluble HIV-1 envelope product that consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505. Study vaccines will be admixed with Adjuplex adjuvant and administered intramuscularly (IM) via needle and syringe in two injection sites.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Department of Health and Human Services
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): volunteer demonstrates understanding of this study, completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly. 2. 18-50 years old, inclusive, on day of enrollment. 3. Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit. 4. Agrees not to enroll in another study of an investigational agent during participation in the trial, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) investigational agents that may subsequently obtain emergency use authorization (EUA) or undergo licensure by the FDA. If a potential participant is already enrolled in a SARS-CoV-2 clinical trial, prior approvals from the SARS-COV-2 study sponsor and HVTN 303 PSRT are required prior to enrollment in HVTN 303. 5. In good general health without clinically significant medical history. 6. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity. 7. Body Mass Index (BMI) ≤ 40. 8. Assessed as low risk for HIV acquisition. 9. Suitable injection sites in the deltoid muscle of each arm, as assessed by a clinician. 10. White blood cells (WBCs) 2,500-12,000/mm3 11. WBC differential either within institutional normal range or approved by the Investigator of Record (IoR) as "not clinically significant." 12. Platelets = 125,000 - 500,000/mm3 13. Hemoglobin * ≥ 11.0 g/dL for volunteers who were assigned female sex at birth * ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months * ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months * For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth 14. Serum creatinine ≤ 1.1 x upper limit of normal (ULN) based on the institutional normal range. 15. Alanine aminotransferase (ALT) ≤1.25 x ULN based on the institutional normal range. 16. Negative for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). 17. Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected. 18. Negative for Hepatitis B surface antigen. 19. Agrees to use effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last product administration. 20. Negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to each study product administration on the day of study product administration.
Exclusion criteria
1. Active duty and reserve US military personnel. 2. Breast-feeding or planning to become pregnant from at least 21 days prior to enrollment through 12 weeks after the last product administration. 3. An investigational HIV vaccine (previous placebo recipients are not excluded). 4. Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatologic condition; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses ≤ 60 mg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment). 5. Blood products within 60 days prior to enrollment 6. Monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 303 PSRT on a case-by-case basis 7. Receipt of any of the following: * Within 4 weeks prior to enrollment: * Any licensed live, attenuated vaccine * Any adenoviral-vectored SARS-CoV-2 vaccine with FDA Emergency Use Authorization (EUA), FDA licensure or World Health Organization (WHO) Emergency Use Listing (EUL) * Within 2 weeks prior to enrollment: * Any licensed killed/subunit/inactivated vaccine * Any mRNA based or protein SARS-CoV-2 vaccines with FDA EUA, FDA licensure, or WHO EUL 8. Investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment. 9. Current allergen immunotherapy with antigen injections, unless on maintenance schedule. 10. Current anti-TB prophylaxis or therapy. 11. Serious adverse reactions to vaccines or vaccine components. 12. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema. 13. Hypertension that is not well controlled. 14. Asthma is excluded if the participant has ANY of the following: * Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR * Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR * Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR * Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist \[LABA\]); OR * Uses more than one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval. 15. Autoimmune disease, current or history, including psoriasis. 16. Clinically significant immunodeficiency. 17. AESIs: Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the product(s) administered in this protocol. 18. History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.). 19. Diabetes mellitus type 1 or type 2. 20. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 21. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years. 22. Asplenia or functional asplenia. 23. Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study). 24. Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, or cancer that, in the clinical judgement of the site investigator, has a potential for recurrence (excluding basal cell carcinoma).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a |
| Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252 | The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point. |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). |
| Number of Participants Reporting Serious Adverse Events (SAEs) | 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose). | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply) |
| Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8. | Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3\*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV\>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. Group 5 and Group 6 were combined in the summary of IgG response rate. |
| Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8. | Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3\*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV\>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. The Unit of Measure is expressed as Mean Electrochemiluminescence Signal\*1/dilution to reflect the AUC of responses across serial dilutions. Group 5 and Group 6 were combined in the summary of IgG magnitudes. |
Countries
United States
Contacts
STUDY_CHAIRTroy Martin
HVTN LOC, Fred Hutch
STUDY_CHAIRMichael Keefer, M.D.
Univ. of Rochester Med. Ctr., HVTU
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) 25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0. | 3 |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) 200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0. | 3 |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) 100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0. | 3 |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) 200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0. | 3 |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) 200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0. | 3 |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0 | 10 |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) 200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4 | 10 |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) 200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4 | 9 |
| Total | 44 |
Baseline characteristics
| Characteristic | Total | Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Part A Group 5: 200 mcg Trimer 4571 at w(0) | Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 28.5 years | 26 years | 34 years | 42 years | 24 years | 32 years | 25.5 years | 31 years | 37 years |
| Age, Customized 18 - 20 years | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Age, Customized 21 - 30 years | 19 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants | 4 Participants | 1 Participants |
| Age, Customized 31 - 40 years | 14 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants |
| Age, Customized 41 - 50 years | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 8 Participants | 7 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 6 Participants | 8 Participants | 8 Participants |
| Region of Enrollment USA | 44 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Female | 17 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 27 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 6 Participants | 7 Participants | 5 Participants |
| Sex/Gender, Customized Female | 15 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 4 Participants |
| Sex/Gender, Customized Gender Queer | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Male | 25 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 6 Participants | 6 Participants | 5 Participants |
| Sex/Gender, Customized Transgender Female (Male to Female) | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender Male (Female to Male) | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 10 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 10 / 10 | 10 / 10 | 9 / 9 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 10 | 0 / 10 | 0 / 9 |
Outcome results
Primary
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3\*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV\>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. The Unit of Measure is expressed as Mean Electrochemiluminescence Signal\*1/dilution to reflect the AUC of responses across serial dilutions. Group 5 and Group 6 were combined in the summary of IgG magnitudes.
Time frame: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.
Population: Overall Number of Participants Analyzed- includes those with samples collected at week 2 for Groups T5+T6, T7, and T8 and week 6 for Groups T7 and T8, who were HIV-uninfected and received the last vaccination. Number Analyzed- counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) | 124.60 Mean ECL Signal*1/dilution |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) | 175.60 Mean ECL Signal*1/dilution |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) | 447.40 Mean ECL Signal*1/dilution |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) | 61.70 Mean ECL Signal*1/dilution |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W6) | 9463.00 Mean ECL Signal*1/dilution |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) | 1462.00 Mean ECL Signal*1/dilution |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W6) | 236.40 Mean ECL Signal*1/dilution |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) | 106.30 Mean ECL Signal*1/dilution |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W6) | 103.00 Mean ECL Signal*1/dilution |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W6) | 572.10 Mean ECL Signal*1/dilution |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) | 557.30 Mean ECL Signal*1/dilution |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W6) | 8568.50 Mean ECL Signal*1/dilution |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) | 87.80 Mean ECL Signal*1/dilution |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W6) | 1192.00 Mean ECL Signal*1/dilution |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) | 118.70 Mean ECL Signal*1/dilution |
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Time frame: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 3 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 2 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 6 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 3 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 5 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 3 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 6 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 3 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 3 Participants |
Primary
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 3 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 9 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 9 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 10 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 7 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 10 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 7 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 5 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 7 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 6 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 2 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 3 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 7 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 4 Participants |
Primary
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 3 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 4 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a
Time frame: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 3 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 3 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 3 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 7 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 3 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 5 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 7 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 6 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 4 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 3 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 7 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 6 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 8 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 4 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 4 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 7 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 3 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 4 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 6 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 5 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | None | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Mild | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Moderate | 5 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Severe | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms* | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 4 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 3 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 6 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 0 Participants |
Primary
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
Primary
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Time frame: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 2 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | 3 Participants |
Primary
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point.
Time frame: T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252
Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 1 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part A, Group 4: 200 mcg Trimer 6931 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 1 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part A Group 5: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 6: 200 mcg Trimer 4571 at w(0) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 1 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Platelets (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 35 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | WBC (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 42 | 1 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 42 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 35 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Creatinine (mg/dL) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 35 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 42 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 35 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 28 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 14 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Hemoglobin (g/dL) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 7 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 259 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 252 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 238 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 231 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 182 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Screening | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 175 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 168 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 154 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 147 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 98 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | ALT (U/L) -Day 140 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Neutrophils (1000 cells/cubic mm) -Day 0 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 91 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 84 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 70 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 63 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 56 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 42 | 0 Participants |
| Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4) | Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table. | Lymphocytes (1000 cells/cubic mm) -Day 35 | 0 Participants |
Primary
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3\*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV\>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. Group 5 and Group 6 were combined in the summary of IgG response rate.
Time frame: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.
Population: Overall Number of Participants Analyzed- includes those with samples collected at week 2 for Groups T5+T6, T7, and T8 and week 6 for Groups T7 and T8, who were HIV-uninfected and received the last vaccination. Number Analyzed- counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) Positivity call method 2 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) Positivity call method 2 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) Positivity call method 1 | 3 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) Positivity call method 1 | 0 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) Positivity call method 1 | 1 Participants |
| Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) Positivity call method 2 | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W6) Positivity call method 2 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W6) Positivity call method 2 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) Positivity call method 1 | 4 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) Positivity call method 2 | 0 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W6) Positivity call method 1 | 3 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W6) Positivity call method 1 | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) Positivity call method 1 | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W6) Positivity call method 2 | 3 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) Positivity call method 1 | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) Positivity call method 2 | 4 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) Positivity call method 2 | 1 Participants |
| Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W6) Positivity call method 1 | 1 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W6) Positivity call method 2 | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) Positivity call method 1 | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W2) Positivity call method 2 | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W6) Positivity call method 1 | 5 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Fusion Peptide (W6) Positivity call method 2 | 5 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) Positivity call method 1 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W2) Positivity call method 2 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W6) Positivity call method 1 | 5 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 4571 (W6) Positivity call method 2 | 3 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) Positivity call method 1 | 2 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W2) Positivity call method 2 | 0 Participants |
| Part A, Group 3: 100 mcg Trimer 6931 at w(0) | Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination. | Trimer 6931 (W6) Positivity call method 1 | 5 Participants |