HIV Infections
Conditions
Keywords
HIV, Vaccine, Infant
Brief summary
This study evaluated the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.
Detailed description
This study evaluated evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE. This study enrolled 38 mother-infant pairs. To quantify the maternal HIV antibody response, mothers were also enrolled in the study but not received study product. Infants received the CH505TF gp120 protein adjuvanted with GLA-SE at Weeks 0, 8, 16, 32, and 54. The first dose was given within the first five days of life. The study was conducted in three parts (Parts A, B, and C), and to ensure safety, enrollment proceeded in stages. Part A (Initial Safety) enrolled first. 5 infants in Part A received a low dose of protein with a low dose of adjuvant and 2 infants received placebo. After safety review post first vaccination of infants in Part A, Part B enrolled. In Part B (Safety Ramp-Up), 2 infants received a higher dose of protein with a higher dose of adjuvant and 2 infants received placebo. After safety review post first vaccination of infants in Part B, Part C enrolled. In Part C (Immunogenicity), 5 infants received low dose protein with higher dose of adjuvant, 16 infants received a higher dose of protein with higher dose of adjuvant, and 6 infants received placebo. There were 14 scheduled clinic visits over 24.5 months. For infants, study visits included some or all of the following: physical examinations, medical history, vaccine injections, HIV testing, and blood, cord blood, and stool collection. For mothers, study visits included some or all of the following: medical history, physical examinations, questionnaires, risk reduction counseling, and blood, breastmilk, and stool collection.
Interventions
BIOLOGICALCH505TF gp120
HIV-1 CH505 transmitted/founder virus Env gp120 immunogen
BIOLOGICALGLA-SE adjuvant
An oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA)
BIOLOGICALPlacebo
Sodium Chloride for Injection, 0.9% USP
Sponsors
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 5 Days
Healthy volunteers
Yes
Inclusion criteria
Infant Inclusion Criteria: * Born via Caesarean section to an HIV-1-infected woman who meets all maternal inclusion/
Exclusion criteria
listed below. * Estimated gestational age at birth is at least 37 weeks. * Weight at birth is at least 2.5 kg. * Has initiated antiretroviral prophylaxis consistent with current site-specific standard of care. * Hemoglobin \>14.0 g/dL. * White Blood Cell Count ≥ 7000 cells/mm3 * Platelets \> 100,000 cells/mm3 * Alanine aminotransferase (ALT) \<1.25 times upper limit of age adjusted normal. * Creatinine \< 1.1 times upper limit of age adjusted normal. * Negative HIV-1 nucleic acid test on specimen drawn within 72 hours of birth. * Written informed consent provided by mother. * Age is equal to or less than five days. Infant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WHO Anthropometric Measure of Weight-for-Age Z-Score | Measured at each study visit. | At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score will be calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. This Outcome Measure was not collected for Mothers. |
| Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | Measured at each study visit. | At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. Z-scores less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. |
| WHO Anthropometric Measure of Weight-for-Length Z-Score | Measured at each study visit. | At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. This Outcome Measure was not collected for Mothers. |
| Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | Measured at each study visit. | At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. Z-scores less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). | 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. This Outcome Measure was not collected for Mothers. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). | 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. This Outcome Measure was not collected for Mothers. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54). | 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: fever, sleepiness/lethargy, rash, vomiting, anorexia, seizure. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities for a participant. This Outcome Measure was not collected for Mothers. |
| Number (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, creatinine, hemoglobin, platelets, and WBC measured at Screening (Day 0) and Days 14, 70, 126, 238, 393, 743; Lymphocytes and Neutrophils measured at Days 14, 70, 126, 238, 393, 743. | 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. This Outcome Measure was not collected for Mothers. |
| Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. | 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). This Outcome Measure was not collected for Mothers. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. | 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). This Outcome Measure was not collected for Mothers. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. | 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). This Outcome Measure was not collected for Mothers. |
| Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | Serum HIV-1-specific IgG responses were measured on a BioPlex instrument (BioRad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. The area under the curve (AUC) was calculated for each participant and antigen using the trapezoidal rule, where the x-axis is log10 dilution and the y-axis is the Net MFI with negative values set to 0. AUC is considered the primary measure of response magnitude. |
| Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination | Measured at month 4.5 (2 weeks post the 3rd vaccination). | HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+. |
| Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations | Measured at month 13 (2 weeks after the 5th vaccination). | HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus) | Measured at month 13, 2 weeks after the 5th vaccination. | PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against diphtheria, tetanus, pertussis, and rubella. The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. A Hepatitis B antigen was tested as part of the PVMA panel, but did not pass lab-internal QC. The lab opted to test this antigen via ELISA and reported those calculated concentration data for analysis in lieu of the HepB PVMA data. A HepB standard was used in each assay for quality control. |
| EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (HiB and RSV) | Measured at month 13, 2 weeks after the 5th vaccination. | PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against Haemophilus influenzae type B (HiB) and respiratory syncytial virus (RSV). The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. |
| Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination. | Measured at month 13, 2 weeks after the 5th vaccination. | Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. All serum samples were assayed against Tier 1 and Tier 2 strains of virus by starting with a 1:10 dilution of serum to obtain a neutralizing antibody titer. ID50 (ID80) titers are defined as the serum dilution that reduces RLUs by 50% (or 80%) relative to the RLUs in virus control wells after subtraction of background. |
| Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | Serum HIV-1-specific FcR responses (1:50 dilution) were measured using the standardized custom HIV-1 Luminex assay on a Luminex FLEXMAP 3D system. Readouts were background-subtracted mean fluorescence intensity (MFI), with background defined by plate-level controls. Net MFI was calculated as experimental minus reference antigen MFI, and values \<1 were set to 1. Post-enrollment samples were considered positive if they met all three criteria: (1) Net MFI ≥ antigen-specific cutoff (95th percentile of HVTN 115 Part A baseline at Day 0) and ≥ 100 above blank; (2) Net MFI \> 3 times the median baseline Net MFI; and (3) MFI \> 3 times the median baseline MFI. Response calls were based on the 1:50 dilution. Data were excluded if the blood draw was outside the allowable window, the participant was HIV positive, reference antigen MFI \> 5,000, or baseline net MFI \> 6,500. |
| Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | Serum HIV-1-specific FcR (dilution 1:50) responses were measured on a Luminex FLEXMAP 3D Instrument System using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
| Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to %GzB activity. A positive response is defined as ≥ 8% GzB activity. |
| Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. |
| Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 \* (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to percent killing or loss of luciferase activity. A positive response is defined as percent specific killing ≥ 15%. |
| Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 \* (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). |
| Response Rate of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. Positivity calls were based on two criteria: 1) Average ADCP score ≥ antigen specific cutoff values (max(95th percentile of HVTN 115 baseline ADCP score, 1)) and 2) Average ADCP score \> 3x antigen specific median HVTN 115 baseline average ADCP score. |
| Magnitude of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination | Measured at month 13, 2 weeks after the 5th vaccination. | ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. |
Countries
South Africa
Contacts
STUDY_CHAIRAvy Violari
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
STUDY_CHAIRGeorgia Tomaras
Duke University, HVTN Laboratory
Participant flow
Recruitment details
This study enrolled 38 mother-infant pairs. Mothers were also enrolled to assess maternal HIV antibody response but did not receive study product. All mother-infant pairs were assigned to Groups as a unit. The values reported reflect the number of infants, who were the primary participants. Each infant corresponds to one unique mother, so the number of mothers equals the number of infants.
Participants by arm
| Arm | Count |
|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54 | 10 |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 5 |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 2 |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 16 |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54 | 5 |
| Total | 38 |
Baseline characteristics
| Characteristic | Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Total | Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) |
|---|---|---|---|---|---|---|
| Age, Continuous | 31.5 years | 34 years | 33 years | 34.5 years | 36 years | 36 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 38 Participants | 5 Participants | 16 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 38 Participants | 5 Participants | 16 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 10 Participants | 38 Participants | 5 Participants | 16 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 1 Participants | 9 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 20 Participants | 4 Participants | 7 Participants | 1 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 | 0 / 2 | 0 / 16 | 0 / 5 |
| other Total, other adverse events | 10 / 10 | 5 / 5 | 2 / 2 | 16 / 16 | 5 / 5 |
| serious Total, serious adverse events | 3 / 10 | 0 / 5 | 1 / 2 | 2 / 16 | 0 / 5 |
Outcome results
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). This Outcome Measure was not collected for Mothers.
Time frame: Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months.
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 16 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
Primary
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
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). This Outcome Measure was not collected for Mothers.
Time frame: Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months.
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Mild | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Moderate | 5 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Severe | 4 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Potentially life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Death | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | No AE reported | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Death | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | No AE reported | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Mild | 2 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Severe | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Potentially life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Moderate | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Potentially life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Death | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Severe | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Moderate | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | No AE reported | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Potentially life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Moderate | 7 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Severe | 4 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | No AE reported | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Death | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Mild | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Death | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Moderate | 4 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | No AE reported | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Potentially life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting AEs, by Highest Severity Grade Per Participant. | Mild | 1 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. This Outcome Measure was not collected for Mothers.
Time frame: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Mild | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 3 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 2 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Mild | 2 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | 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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 16 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Mild | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 16 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Mild | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 16 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Mild | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Mild | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 5 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. This Outcome Measure was not collected for Mothers.
Time frame: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 4 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 0 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). This Outcome Measure was not collected for Mothers.
Time frame: Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Serious Adverse Events (SAEs) | 3 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Serious Adverse Events (SAEs) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | 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: fever, sleepiness/lethargy, rash, vomiting, anorexia, seizure. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities for a participant. This Outcome Measure was not collected for Mothers.
Time frame: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | None | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Mild | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Mild | 4 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Mild | 3 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | None | 7 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | None | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Moderate | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | None | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | None | 6 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Mild | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | None | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Potentially Life-threatening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Severe | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Mild | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Mild | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | None | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | None | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | None | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Mild | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | None | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 4 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | None | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Severe | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | None | 4 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Severe | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | None | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Mild | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | None | 13 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Mild | 3 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | None | 16 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Mild | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | None | 13 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Mild | 3 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | None | 8 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Mild | 8 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | None | 11 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Mild | 5 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Severe | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Potentially Life-threatening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | None | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Moderate | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Moderate | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | Mild | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | None | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Sleepiness/lethargy | None | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Mild | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | Mild | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Seizure | None | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | None | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | None | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Severe | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Rash | Potentially Life-threatening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Anorexia | Mild | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | Mild | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Sypmtoms | None | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
Primary
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. Z-scores less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length.
Time frame: Measured at each study visit.
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 2) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Screening Visit) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 4) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Screening Visit) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 10 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Screening Visit) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Screening Visit) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 2) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 3 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 2 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Screening Visit) | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Screening Visit) | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Screening Visit) | 16 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 2) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 16 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 13 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 13 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 13 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 4) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Screening Visit) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 14 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 5) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 16 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 4 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Screening Visit) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 4 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Screening Visit) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (14 Days Post Vaccination 2) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 5 Participants |
Primary
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. Z-scores less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight.
Time frame: Measured at each study visit.
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 2) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 3) | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 7 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 5) | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 7 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 9 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Screening Visit) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Screening Visit) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 1) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 4) | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 10 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 8 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Screening Visit) | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 9 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 2) | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Screening Visit) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Screening Visit) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 4 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 4 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 3 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 4 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 5 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Screening Visit) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Screening Visit) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 2) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 3) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 4) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 2 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 3 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 5 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 10 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 11 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 11 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 4) | 3 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 1) | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 14 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Screening Visit) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Screening Visit) | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 5) | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 11 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 3 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 13 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 15 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 3) | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 2) | 4 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Screening Visit) | 12 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 4/Prior to Vaccination 3) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (1 Day Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 8/Prior to Vaccination 4) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 2) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 2) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (4.5 Months Post Vaccination 5) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (4.5 Months Post Vaccination 5) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 8/Prior to Vaccination 4) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 2/Prior to Vaccination 2) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 2) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 0/Prior to Vaccination 1) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 5) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 2/Prior to Vaccination 2) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (1 Day Post Vaccination 1) | 4 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 3) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 4/Prior to Vaccination 3) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 4) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 2/Prior to Vaccination 2) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 8/Prior to Vaccination 4) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (12.5 Months Post Vaccination 5) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 5) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 4) | 2 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (1 Day Post Vaccination 1) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 0/Prior to Vaccination 1) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (12.5 Months Post Vaccination 5) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 12.5/Prior to Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 1) | 5 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (14 Days Post Vaccination 3) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (12.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (4.5 Months Post Vaccination 5) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Month 12.5/Prior to Vaccination 5) | 4 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Screening Visit) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 0/Prior to Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Screening Visit) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (14 Days Post Vaccination 3) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | >2 (Month 12.5/Prior to Vaccination 5) | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (14 Days Post Vaccination 1) | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | -2 to 2 (Screening Visit) | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories | <-2 (Month 4/Prior to Vaccination 3) | 0 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. This Outcome Measure was not collected for Mothers.
Time frame: ALT, creatinine, hemoglobin, platelets, and WBC measured at Screening (Day 0) and Days 14, 70, 126, 238, 393, 743; Lymphocytes and Neutrophils measured at Days 14, 70, 126, 238, 393, 743.
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) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 743 | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 393 | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 126 | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 | 7 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 | 4 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 1 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 126 | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 2 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 1 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 2 Participants |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 1 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 7 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 7 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 2 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 1 Participants |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 3 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Screening | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 393 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 70 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 14 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 238 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 (cells/cubic mm) - Day 126 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 | 1 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 743 | 0 Participants |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | Number (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 |
Primary
WHO Anthropometric Measure of Weight-for-Age Z-Score
At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score will be calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. This Outcome Measure was not collected for Mothers.
Time frame: Measured at each study visit.
Population: Safety population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Screening Visit | -0.32 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 8/Prior to Vaccination 4 | 0.12 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 4/Prior to Vaccination 3 | -0.04 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 3 | 0.11 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 4.5 Months Post Vaccination 5 | -0.27 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 1 Day Post Vaccination 1 | -0.47 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 5 | -0.18 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 1 | -0.50 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 12.5 Months Post Vaccination 5 | -0.05 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 12.5/Prior to Vaccination 5 | -0.03 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 2 | -0.50 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 2/Prior to Vaccination 2 | -0.25 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 0/Prior to Vaccination 1 | -0.54 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 4 | 0.23 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 4 | -0.69 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 8/Prior to Vaccination 4 | -0.76 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 1 | -0.53 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 4/Prior to Vaccination 3 | -0.44 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 0/Prior to Vaccination 1 | -1.16 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 3 | -0.56 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 2/Prior to Vaccination 2 | 0.15 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Screening Visit | -0.80 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 4.5 Months Post Vaccination 5 | -1.17 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 12.5/Prior to Vaccination 5 | -0.25 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 2 | 0.22 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 1 Day Post Vaccination 1 | -1.13 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 12.5 Months Post Vaccination 5 | -0.70 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 5 | -0.39 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 2 | -1.30 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Screening Visit | -1.59 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 0/Prior to Vaccination 1 | -1.36 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 1 Day Post Vaccination 1 | -1.39 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 1 | -1.02 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 2/Prior to Vaccination 2 | -1.27 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 4/Prior to Vaccination 3 | -1.43 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 3 | -1.41 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 8/Prior to Vaccination 4 | -1.69 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 4 | -1.71 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 12.5/Prior to Vaccination 5 | -1.30 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 5 | -1.20 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 4.5 Months Post Vaccination 5 | -1.28 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 12.5 Months Post Vaccination 5 | -0.08 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 2 | 0.02 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 8/Prior to Vaccination 4 | -0.09 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 2/Prior to Vaccination 2 | -0.34 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 4 | -0.04 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 1 | -0.29 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Screening Visit | -0.29 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 12.5/Prior to Vaccination 5 | 0.29 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 1 Day Post Vaccination 1 | -0.44 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 5 | 0.52 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 0/Prior to Vaccination 1 | -0.47 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 12.5 Months Post Vaccination 5 | 0.14 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 4/Prior to Vaccination 3 | -0.38 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 4.5 Months Post Vaccination 5 | -0.11 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 3 | -0.39 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 4/Prior to Vaccination 3 | -0.31 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 12.5 Months Post Vaccination 5 | 0.24 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 8/Prior to Vaccination 4 | 0.60 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 2/Prior to Vaccination 2 | 0.07 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 3 | 0.24 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Screening Visit | 0.60 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 5 | 0.14 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 4 | -0.20 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 1 | 0.03 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 0/Prior to Vaccination 1 | 0.06 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 14 Days Post Vaccination 2 | -0.04 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 4.5 Months Post Vaccination 5 | 1.08 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | Month 12.5/Prior to Vaccination 5 | -0.14 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Age Z-Score | 1 Day Post Vaccination 1 | -0.05 Z-scores |
Primary
WHO Anthropometric Measure of Weight-for-Length Z-Score
At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. This Outcome Measure was not collected for Mothers.
Time frame: Measured at each study visit.
Population: Safety population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 12.5 Months Post Vaccination 5 | 1.06 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 8/Prior to Vaccination 4 | 1.07 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 4/Prior to Vaccination 3 | 1.55 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 0/Prior to Vaccination 1 | 0.20 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 3 | 1.55 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 4.5 Months Post Vaccination 5 | 0.68 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 1 Day Post Vaccination 1 | 0.40 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 5 | 0.66 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 1 | 0.53 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Screening Visit | 0.97 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 12.5/Prior to Vaccination 5 | 0.96 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 2/Prior to Vaccination 2 | 1.07 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 4 | 1.11 Z-scores |
| Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 2 | 1.14 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 8/Prior to Vaccination 4 | 0.67 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 12.5/Prior to Vaccination 5 | 0.91 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 3 | 0.48 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 2/Prior to Vaccination 2 | 2.43 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 4/Prior to Vaccination 3 | 0.91 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 1 | 0.84 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 12.5 Months Post Vaccination 5 | 0.72 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 0/Prior to Vaccination 1 | -0.44 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 4.5 Months Post Vaccination 5 | 0.08 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 2 | 1.11 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 5 | 0.93 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 4 | 0.68 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 1 Day Post Vaccination 1 | 0.44 Z-scores |
| Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Screening Visit | -0.95 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 0/Prior to Vaccination 1 | -0.68 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Screening Visit | -2.30 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 1 Day Post Vaccination 1 | -0.58 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 1 | 0.50 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 2/Prior to Vaccination 2 | 0.89 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 2 | 0.88 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 4/Prior to Vaccination 3 | 0.82 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 3 | -0.02 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 8/Prior to Vaccination 4 | -0.49 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 4 | 0.18 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 12.5/Prior to Vaccination 5 | -0.04 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 5 | 0.63 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 4.5 Months Post Vaccination 5 | -0.36 Z-scores |
| Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 12.5 Months Post Vaccination 5 | 0.59 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 1 | 0.74 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 2/Prior to Vaccination 2 | 1.60 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 5 | 0.65 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Screening Visit | 0.50 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 0/Prior to Vaccination 1 | 0.02 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 4 | 0.69 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 12.5 Months Post Vaccination 5 | 1.05 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 12.5/Prior to Vaccination 5 | 0.79 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 4/Prior to Vaccination 3 | 1.04 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 8/Prior to Vaccination 4 | 1.01 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 4.5 Months Post Vaccination 5 | 0.89 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 3 | 1.16 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 1 Day Post Vaccination 1 | 0.06 Z-scores |
| Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 2 | 1.41 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 0/Prior to Vaccination 1 | 0.44 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 4.5 Months Post Vaccination 5 | 0.79 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 8/Prior to Vaccination 4 | 0.96 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 1 | 0.47 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Screening Visit | 0.93 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 4 | 0.45 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 1 Day Post Vaccination 1 | 0.05 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 12.5/Prior to Vaccination 5 | 1.39 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 2/Prior to Vaccination 2 | 1.25 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 12.5 Months Post Vaccination 5 | 1.70 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 5 | 1.71 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | Month 4/Prior to Vaccination 3 | 0.99 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 2 | 1.88 Z-scores |
| Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54) | WHO Anthropometric Measure of Weight-for-Length Z-Score | 14 Days Post Vaccination 3 | 0.69 Z-scores |