Group B Streptococcal Infections
Conditions
Brief summary
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.
Detailed description
Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts. Participants will be involved in the study for approximately one year including screening and safety follow-up. Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively.
Interventions
BIOLOGICALGBS-NN/NN2
GBS-NN/NN2 bound to alhydrogel as an adjuvant
BIOLOGICALPlacebo
Normal Saline 0.9 %
Sponsors
Iqvia Pty Ltd
Minervax ApS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participants aged 55 to 75 years. 2. Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants. 3. Able to voluntarily provide written informed consent to participate in the study. 4. Female participants must be post-menopausal. 5. Participants capable and willing to follow trial schedule and procedures.
Exclusion criteria
1. Participants who have received a GBS vaccine previously. 2. Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection. NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4. 3. Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal. 4. Current or history of drug or alcohol abuse per investigator judgement. 5. Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. 6. Participants currently participating in a clinical trial. 7. Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study. 8. Any significant illness during the 4 weeks preceding the vaccination visit, per investigator judgement. 9. Participants with a history of severe allergic reactions after previous vaccination. 10. Participants who have received any vaccine within 30 days of first IMP administration, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each vaccination. NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days before or after study vaccination. 11. Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months prior to screening. 12. Participants within a 7-day period after an acute infection in the 7 days preceding vaccination, as per investigator judgement, or with fever (oral temperature \>37.9°C) in the 72 hours preceding vaccination. 13. Participants who have received antipyretics/analgesics treatment within 72 hours prior to dosing. 14. Participants on chronic medications that are likely to affect the assessments specified in the protocol (eg, anticoagulant therapy, systemic steroids). NOTE: Chronic medications such as antihypertensives, bronchodilators, statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the investigator. Treatment for diabetes will be continued as required for the diabetic participants recruited. Non-steroidal anti-inflammatory drugs or paracetamol will be permitted for the treatment of headache or other symptoms during the study. Use of over the counter (OTC) vitamins and dietary supplements is allowed. 15. Participants with skin defects and/or tattoos at the proposed site of vaccine administration. 16. Donation of blood or blood products within 90 days prior to first study vaccination. 17. Participants who, in the opinion of the Investigator, are unsuitable for participation in the study. 18. Involvement in the planning and/or conduct of the study (applies to both Sponsor personnel and/or personnel at the study centre or Clinical Research Organisation \[CRO\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Up to 28 days after each vaccination | * Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Day 197 | Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint). |
| Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | 4 weeks after each vaccination (Days 29, 57 and 197) | Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination. |
| Seroconversion Rate at Any Time Post Vaccination | Up to 6 months after last vaccination | Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response. |
| Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Up to day 197 | Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (\>1, \>2, \>4, and \>8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose. |
| Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | Up to day 365 | * Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. * Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365. |
Countries
Belgium
Participant flow
Recruitment details
Overall, 90 participants were enrolled and randomised.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 24 |
| Healthy Older Adult : GBS-NN/NN2 125 µg Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 24 |
| Healthy Older Adult : Placebo Healthy older adult received three injections of placebo.
Placebo: Normal Saline 0.9 % | 12 |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 12 |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide.
GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 12 |
| Obese and/or Diabetic Older Adult : Placebo Obese and/or diabetic older adults received three injections of placebo.
Placebo: Normal Saline 0.9 % | 6 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Healthy Older Adult : GBS-NN/NN2 50 µg | Total | Obese and/or Diabetic Older Adult : Placebo | Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Healthy Older Adult : Placebo | Healthy Older Adult : GBS-NN/NN2 125 µg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 5.4 | 65.1 years STANDARD_DEVIATION 5.1 | 65.8 years STANDARD_DEVIATION 1.3 | 65.4 years STANDARD_DEVIATION 4.6 | 64.5 years STANDARD_DEVIATION 6 | 65.8 years STANDARD_DEVIATION 5 | 64.5 years STANDARD_DEVIATION 5.5 |
| Body Mass Index (BMI) | 24.993 kg/m^2 STANDARD_DEVIATION 2.537 | 27.476 kg/m^2 STANDARD_DEVIATION 4.772 | 32.437 kg/m^2 STANDARD_DEVIATION 5.123 | 33.323 kg/m^2 STANDARD_DEVIATION 3.34 | 32.262 kg/m^2 STANDARD_DEVIATION 1.584 | 24.668 kg/m^2 STANDARD_DEVIATION 3.856 | 24.808 kg/m^2 STANDARD_DEVIATION 2.854 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 90 Participants | 6 Participants | 12 Participants | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.81 cm STANDARD_DEVIATION 10.5 | 169.03 cm STANDARD_DEVIATION 9.65 | 172.00 cm STANDARD_DEVIATION 14.49 | 169.15 cm STANDARD_DEVIATION 11.67 | 171.88 cm STANDARD_DEVIATION 9.36 | 167.12 cm STANDARD_DEVIATION 7.85 | 168.98 cm STANDARD_DEVIATION 7.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 89 Participants | 6 Participants | 12 Participants | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Female | 11 Participants | 45 Participants | 4 Participants | 8 Participants | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 45 Participants | 2 Participants | 4 Participants | 5 Participants | 8 Participants | 13 Participants |
| Weight | 70.98 Kg STANDARD_DEVIATION 13.16 | 78.76 Kg STANDARD_DEVIATION 16.41 | 95.07 Kg STANDARD_DEVIATION 11.91 | 95.38 Kg STANDARD_DEVIATION 14.09 | 95.68 Kg STANDARD_DEVIATION 12.54 | 68.88 Kg STANDARD_DEVIATION 11.75 | 70.65 Kg STANDARD_DEVIATION 7.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 6 |
| other Total, other adverse events | 17 / 24 | 16 / 24 | 10 / 12 | 9 / 12 | 9 / 12 | 4 / 6 |
| serious Total, serious adverse events | 1 / 24 | 1 / 24 | 2 / 12 | 1 / 12 | 0 / 12 | 0 / 6 |
Outcome results
Primary
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
Time frame: Up to 28 days after each vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Systemic Solicited AEs | 12 Participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | AEs leading to withdrawal | 0 Participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Unsolicited AEs | 17 Participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Local Solicited AEs | 23 Participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | AEs leading to withdrawal | 0 Participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Systemic Solicited AEs | 14 Participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Local Solicited AEs | 21 Participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Unsolicited AEs | 16 Participants |
| Healthy Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Local Solicited AEs | 5 Participants |
| Healthy Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | AEs leading to withdrawal | 2 Participants |
| Healthy Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Unsolicited AEs | 10 Participants |
| Healthy Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Systemic Solicited AEs | 6 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Local Solicited AEs | 10 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Systemic Solicited AEs | 8 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Unsolicited AEs | 9 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | AEs leading to withdrawal | 0 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Systemic Solicited AEs | 7 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Local Solicited AEs | 10 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Unsolicited AEs | 9 Participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | AEs leading to withdrawal | 0 Participants |
| Obese and/or Diabetic Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | AEs leading to withdrawal | 0 Participants |
| Obese and/or Diabetic Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Local Solicited AEs | 2 Participants |
| Obese and/or Diabetic Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Systemic Solicited AEs | 4 Participants |
| Obese and/or Diabetic Older Adult : Placebo | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine | Unsolicited AEs | 4 Participants |
Secondary
Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint).
Time frame: Day 197
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp1 | 13.14 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp2/3 | 12.69 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-AlpC | 13.69 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Rib | 4.76 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-AlpC | 11.28 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp2/3 | 17.39 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp1 | 12.34 μg/mL |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Rib | 4.55 μg/mL |
| Healthy Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Rib | 0.04 μg/mL |
| Healthy Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-AlpC | 0.04 μg/mL |
| Healthy Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp2/3 | 0.04 μg/mL |
| Healthy Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp1 | 0.08 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp1 | 8.34 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Rib | 3.67 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp2/3 | 10.90 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-AlpC | 6.64 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-AlpC | 14.11 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Rib | 4.59 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp2/3 | 14.52 μg/mL |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp1 | 14.17 μg/mL |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp2/3 | 0.09 μg/mL |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-AlpC | 0.10 μg/mL |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Rib | 0.06 μg/mL |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Anti-Alp1 | 0.15 μg/mL |
Secondary
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination.
Time frame: 4 weeks after each vaccination (Days 29, 57 and 197)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 29 | 59.09 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 57 | 102.29 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1- Day 57 | 70.98 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 29 | 34.04 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 197 | 47.74 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 197 | 124.30 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 57 | 30.74 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 29 | 40.97 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 57 | 72.60 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 29 | 18.56 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 197 | 148.15 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 197 | 115.60 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 57 | 34.87 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 29 | 31.75 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 197 | 204.85 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 197 | 106.77 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 29 | 50.32 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 57 | 38.89 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 29 | 26.62 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 29 | 24.99 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 197 | 69.42 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 197 | 114.30 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1- Day 57 | 39.71 Geometric mean fold ratio |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 57 | 76.23 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1- Day 57 | 1.09 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 57 | 1.03 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 57 | 1.09 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 29 | 1.04 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 197 | 0.85 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 197 | 0.45 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 29 | 0.98 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 29 | 1.03 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 29 | 1.10 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 197 | 0.69 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 57 | 1.15 Geometric mean fold ratio |
| Healthy Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 197 | 0.68 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 197 | 56.11 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 197 | 89.51 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 29 | 21.27 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1- Day 57 | 32.86 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 29 | 20.17 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 57 | 39.29 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 29 | 29.37 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 57 | 40.66 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 197 | 60.42 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 29 | 25.74 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 57 | 36.74 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 197 | 54.05 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 57 | 84.82 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 197 | 114.75 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 29 | 43.16 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 197 | 37.74 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 57 | 24.06 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 29 | 82.64 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1- Day 57 | 47.89 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 197 | 91.27 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 29 | 45.62 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 29 | 20.95 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 57 | 44.84 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 197 | 205.88 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 57 | 0.87 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 57 | 0.88 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 197 | 0.95 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 29 | 0.66 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 197 | 0.58 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 29 | 1.00 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 197 | 1.46 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1- Day 57 | 0.84 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Rib - Day 57 | 1.10 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | AlpC - Day 29 | 0.63 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp1 - Day 29 | 0.78 Geometric mean fold ratio |
| Obese and/or Diabetic Older Adult : Placebo | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Alp2/3 - Day 197 | 1.09 Geometric mean fold ratio |
Secondary
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
* Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. * Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.
Time frame: Up to day 365
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | ARs/SARs from Day 197 up to Day 365 | 0 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | MAAEs from Day 197 up to Day 365 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 57 to Day 168 | 0 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | AESIs from Day 197 up to Day 365 | 0 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 197 to Day 365 | 0 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 197 to Day 365 | 1 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | ARs/SARs from Day 197 up to Day 365 | 0 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | MAAEs from Day 197 up to Day 365 | 9 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | AESIs from Day 197 up to Day 365 | 0 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 57 to Day 168 | 0 participants |
| Healthy Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 57 to Day 168 | 1 participants |
| Healthy Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 197 to Day 365 | 1 participants |
| Healthy Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | MAAEs from Day 197 up to Day 365 | 2 participants |
| Healthy Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | AESIs from Day 197 up to Day 365 | 1 participants |
| Healthy Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | ARs/SARs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 197 to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | ARs/SARs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | AESIs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | MAAEs from Day 197 up to Day 365 | 1 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 57 to Day 168 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | AESIs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | MAAEs from Day 197 up to Day 365 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | ARs/SARs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 197 to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 57 to Day 168 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | MAAEs from Day 197 up to Day 365 | 2 participants |
| Obese and/or Diabetic Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 57 to Day 168 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | ARs/SARs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | AESIs from Day 197 up to Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) | SAE from Day 197 to Day 365 | 0 participants |
Secondary
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (\>1, \>2, \>4, and \>8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose.
Time frame: Up to day 197
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 29 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 29 | 8 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 29 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 169 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 169 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 169 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 57 | 17 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 29 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 29 | 13 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 57 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 29 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 169 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 197 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 29 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 197 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 57 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 169 | 6 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 29 | 17 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 57 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 169 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 169 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 57 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 57 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 29 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 57 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 197 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 29 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 169 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 169 | 5 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 197 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 29 | 13 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 57 | 9 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 197 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 29 | 7 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 29 | 6 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 169 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 29 | 3 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 57 | 17 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 57 | 5 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 57 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 29 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 169 | 3 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 197 | 9 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 57 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 169 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 57 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 29 | 15 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 57 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 169 | 15 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 169 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 157 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 57 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 197 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 169 | 8 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 169 | 5 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 57 | 13 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 57 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 29 | 5 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 169 | 2 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 197 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 29 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 197 | 17 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 29 | 5 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 169 | 7 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 157 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 169 | 19 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 197 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 57 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 57 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 169 | 10 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 29 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 169 | 5 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 29 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 29 | 17 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 169 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 169 | 4 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 57 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 169 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 169 | 14 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 197 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 29 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 57 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 57 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 197 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 29 | 2 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 197 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 29 | 7 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 57 | 1 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 29 | 17 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 57 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 169 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 29 | 9 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 169 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 29 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 57 | 8 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 57 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 169 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 29 | 15 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 29 | 11 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 197 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 169 | 1 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 29 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 57 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 197 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 29 | 12 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 57 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 57 | 9 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 169 | 4 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 197 | 9 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 169 | 14 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 169 | 16 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 57 | 18 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 57 | 7 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 57 | 18 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 157 | 0 participants |
| Healthy Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 169 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 197 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 29 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 169 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 29 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 169 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 157 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 57 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 57 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 29 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 29 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 169 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 169 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 197 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 169 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 29 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 29 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 197 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 169 | 1 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 169 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 57 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 169 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 57 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 29 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 29 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 57 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 169 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 169 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 57 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 197 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 197 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 57 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 197 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 29 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 57 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 29 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 169 | 1 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 57 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 29 | 2 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 197 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 169 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 169 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 197 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 169 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 57 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 169 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 197 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 169 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 29 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 57 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 57 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 157 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 197 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 29 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 169 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 29 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 169 | 2 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 57 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 197 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 57 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 57 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 29 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 169 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 29 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 57 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 169 | 2 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 197 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 169 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 57 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 169 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 197 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 29 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 169 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 57 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 57 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 169 | 4 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 169 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 197 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 29 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 169 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 57 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 197 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 29 | 3 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 29 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 197 | 5 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 29 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 57 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 169 | 2 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 57 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 169 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 169 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 29 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 169 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 57 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 57 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 169 | 6 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 197 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 57 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 157 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >8 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >8 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >1 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >4 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >1 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >1 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >8 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >2 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >2 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >4 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >4 µg/mL - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >2 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | AlpC >8 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp 1 >2 µg/mL - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Rib >4 µg/mL - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Alp2/3 >1 µg/mL - Day 197 | 0 participants |
Secondary
Seroconversion Rate at Any Time Post Vaccination
Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Time frame: Up to 6 months after last vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 29 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 (µg/mL) - Day 29 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 197 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 365 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 169 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 365 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 57 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 365 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 365 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 57 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 169 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 169 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 29 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 29 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 57 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 57 | 23 participants |
| Healthy Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 169 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 365 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 57 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 57 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 29 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 29 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 (µg/mL) - Day 29 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 365 | 22 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 365 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 169 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 57 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 169 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 197 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 169 | 20 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 169 | 21 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 365 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 57 | 24 participants |
| Healthy Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 29 | 23 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 365 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 365 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 169 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 57 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 (µg/mL) - Day 29 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 365 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 197 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 365 | 0 participants |
| Healthy Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 365 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 (µg/mL) - Day 29 | 9 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 57 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 169 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 365 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 29 | 7 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 57 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 169 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 365 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 29 | 8 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 57 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 169 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 29 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 57 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 169 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 365 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 29 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 365 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 169 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 365 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 57 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 29 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 29 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 (µg/mL) - Day 29 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 57 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 365 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 197 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 169 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 169 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 57 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 365 | 10 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 57 | 12 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 197 | 11 participants |
| Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 169 | 10 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 197 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 365 | 2 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 197 | 2 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 197 | 1 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 197 | 1 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 169 | 1 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 169 | 2 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 365 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 169 | 1 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 (µg/mL) - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-AlpC - Day 57 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 29 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Rib - Day 169 | 0 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp1 - Day 365 | 1 participants |
| Obese and/or Diabetic Older Adult : Placebo | Seroconversion Rate at Any Time Post Vaccination | Anti-Alp2/3 - Day 365 | 0 participants |