FindTrial
Sign In

A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01193582
Acronym
6114A1-4000-CN
Enrollment
505
Registered
2010-09-02
Start date
2010-09-30
Completion date
2012-09-30
Last updated
2013-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Keywords

Prevenar, catch-up, pneumococcal, pneumonia

Brief summary

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae. This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.

Interventions

BIOLOGICALPrevenar

Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to \< 212 days of age

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
121 Days to 72 Months
Healthy volunteers
Yes

Inclusion criteria

* Healthy Chinese male or female subjects. * Between 121 days to less than 72 months of age at the time of entry into the study.

Exclusion criteria

* Receipt of previous vaccine against Pneumo * Previous anaphylactic reaction to any vaccine or part of a vaccine * Previous proven invasive Pneumo infection * Receipt of investigational drug or device within the proceeding 28 days

Design outcomes

Primary

MeasureTime frameDescription
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar1 month after last dose in each groupSerotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupBaselineSerotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Secondary

MeasureTime frameDescription
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 21 month after second dose of Prevenar in Group 2Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Pre-vaccination to 1 month after second dose of Prevenar in Group 2GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 31 month after first dose of Prevenar in Group 3Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 11 month after third dose of Prevenar in Group 1Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.12 months after the last doseSerotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Pre-vaccination to 12 months after the last doseGMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Pre-vaccination to 1 month after first dose of Prevenar in Group 3GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Pre-vaccination to 1 month after third dose of Prevenar in Group 1GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

Countries

China

Participant flow

Recruitment details

This report presents results following completion of all vaccinations, including data from the 12-month follow-up. This study was conducted at one site in China.

Pre-assignment details

Participants were enrolled into 1 of 4 groups based on inclusion/exclusion criteria without a screening period.

Participants by arm

ArmCount
Group 1
Participants 121 to \<212 days of age and received 4 doses of Prevenar.
88
Group 2
Participants 212 days to \<12 months of age (before the first birthday) and received 3 doses of Prevenar.
87
Group 3
Participants 12 to \<24 months of age (before the second birthday) and received 2 doses of Prevenar
115
Group 4
Participants 24 to \<72 months of age (before the sixth birthday) and received 1 dose of Prevenar
177
Total467

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
12 Month Follow-upDeath0010
12 Month Follow-upWithdrawal by Subject60311
Vaccination SeriesWithdrawal by Subject111383

Baseline characteristics

CharacteristicGroup 1Group 2Group 3Group 4Total
Age Continuous5.3 Months
STANDARD_DEVIATION 0.9
9.8 Months
STANDARD_DEVIATION 1.4
17.5 Months
STANDARD_DEVIATION 4.2
44.5 Months
STANDARD_DEVIATION 13
24.0 Months
STANDARD_DEVIATION 18.5
Sex: Female, Male
Female
50 Participants43 Participants58 Participants93 Participants244 Participants
Sex: Female, Male
Male
38 Participants44 Participants57 Participants84 Participants223 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
3 / 1004 / 1003 / 1251 / 180
serious
Total, serious adverse events
1 / 1000 / 1001 / 1250 / 180

Outcome results

Primary

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar

Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Time frame: 1 month after last dose in each group

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 19F (n= 87, 87, 115, 177)4.05 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 4 (n= 88, 87, 115, 177)6.90 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 6B (n= 88, 87, 114, 177)8.01 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 9V (n= 88, 87, 115, 177)4.11 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 14 (n= 88, 87, 115, 177)12.75 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 18C (n= 88, 87, 115, 177)4.65 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 23F (n= 88, 87, 115, 177)4.75 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 23F (n= 88, 87, 115, 177)3.95 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 14 (n= 88, 87, 115, 177)13.02 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 19F (n= 87, 87, 115, 177)4.02 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 9V (n= 88, 87, 115, 177)4.64 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 4 (n= 88, 87, 115, 177)7.16 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 18C (n= 88, 87, 115, 177)4.65 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 6B (n= 88, 87, 114, 177)5.79 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 18C (n= 88, 87, 115, 177)5.40 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 19F (n= 87, 87, 115, 177)4.03 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 4 (n= 88, 87, 115, 177)7.53 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 6B (n= 88, 87, 114, 177)4.81 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 14 (n= 88, 87, 115, 177)11.98 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 23F (n= 88, 87, 115, 177)4.18 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 9V (n= 88, 87, 115, 177)4.67 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 19F (n= 87, 87, 115, 177)4.53 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 6B (n= 88, 87, 114, 177)6.36 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 23F (n= 88, 87, 115, 177)5.64 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 9V (n= 88, 87, 115, 177)6.14 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 14 (n= 88, 87, 115, 177)9.86 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 18C (n= 88, 87, 115, 177)7.39 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in PrevenarSerotype 4 (n= 88, 87, 115, 177)9.45 μg/mL
Primary

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group

Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame: Baseline

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 4 (n= 88, 87, 115, 172)0.01 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 19F (n= 88, 85, 115, 169)0.11 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 18C (n= 88, 87, 114, 172)0.04 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 6B (n= 86, 64, 100, 177)0.12 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 23F (n= 85, 75, 102, 174)0.07 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 9V (n= 88, 84, 113, 177)0.10 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 14 (n= 88, 87, 115, 177)0.16 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 19F (n= 88, 85, 115, 169)0.09 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 14 (n= 88, 87, 115, 177)0.04 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 9V (n= 88, 84, 113, 177)0.10 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 18C (n= 88, 87, 114, 172)0.02 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 23F (n= 85, 75, 102, 174)0.08 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 6B (n= 86, 64, 100, 177)0.16 μg/mL
Group 2Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 4 (n= 88, 87, 115, 172)0.01 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 14 (n= 88, 87, 115, 177)0.03 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 4 (n= 88, 87, 115, 172)0.02 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 6B (n= 86, 64, 100, 177)0.27 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 9V (n= 88, 84, 113, 177)0.17 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 18C (n= 88, 87, 114, 172)0.02 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 19F (n= 88, 85, 115, 169)0.13 μg/mL
Group 3Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 23F (n= 85, 75, 102, 174)0.17 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 9V (n= 88, 84, 113, 177)0.66 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 23F (n= 85, 75, 102, 174)0.88 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 19F (n= 88, 85, 115, 169)0.71 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 6B (n= 86, 64, 100, 177)1.30 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 4 (n= 88, 87, 115, 172)0.06 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 18C (n= 88, 87, 114, 172)0.12 μg/mL
Group 4Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each GroupSerotype 14 (n= 88, 87, 115, 177)0.36 μg/mL
Secondary

Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.

Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame: 12 months after the last dose

Population: Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 162)0.78 μg/mL
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 19F (n= 80, 76, 109, 156)1.25 μg/mL
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 111, 162)0.87 μg/mL
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 6B (n= 81, 78, 109, 161)3.22 μg/mL
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 23F (n= 81, 78, 110, 162)1.38 μg/mL
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 9V (n= 81, 79, 111, 162)1.26 μg/mL
Group 1Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)1.84 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 19F (n= 80, 76, 109, 156)1.29 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)2.18 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 9V (n= 81, 79, 111, 162)0.98 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 111, 162)0.71 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 23F (n= 81, 78, 110, 162)1.20 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 6B (n= 81, 78, 109, 161)2.31 μg/mL
Group 2Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 162)0.65 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)2.61 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 162)0.96 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 6B (n= 81, 78, 109, 161)2.38 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 9V (n= 81, 79, 111, 162)1.44 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 111, 162)0.98 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 19F (n= 80, 76, 109, 156)1.39 μg/mL
Group 3Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 23F (n= 81, 78, 110, 162)1.79 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 9V (n= 81, 79, 111, 162)2.23 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 23F (n= 81, 78, 110, 162)2.49 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 19F (n= 80, 76, 109, 156)2.85 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 6B (n= 81, 78, 109, 161)4.20 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 162)1.27 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 111, 162)1.46 μg/mL
Group 4Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)5.19 μg/mL
Secondary

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3

Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame: 1 month after first dose of Prevenar in Group 3

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 4 (n= 115)8.44 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 6B (n= 113)1.92 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 9V (n= 115)4.77 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 14 (n= 115)3.37 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 18C (n= 115)5.72 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 19F (n= 113)1.96 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3Serotype 23F (n= 115)2.83 μg/mL
Secondary

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2

Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame: 1 month after second dose of Prevenar in Group 2

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 4 (n= 87)8.46 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 6B (n= 85)2.67 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 9V (n= 87)4.71 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 14 (n= 87)8.05 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 18C (n= 87)4.93 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 19F (n= 87)3.03 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2Serotype 23F (n= 87)2.66 μg/mL
Secondary

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1

Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame: 1 month after third dose of Prevenar in Group 1

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 4 (n= 88)6.38 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 6B (n= 87)2.88 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 9V (n= 88)4.18 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 14 (n= 88)11.16 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 18C (n= 88)4.60 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 19F (n= 88)3.60 μg/mL
Group 1Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1Serotype 23F (n= 88)2.45 μg/mL
Secondary

Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.

GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

Time frame: Pre-vaccination to 1 month after third dose of Prevenar in Group 1

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 4 (n= 88)453.17 Fold rise
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 6B (n= 85)23.10 Fold rise
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 9V (n= 88)43.38 Fold rise
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 14 (n= 88)69.90 Fold rise
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 18C (n= 88)106.74 Fold rise
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 19F (n= 88)32.52 Fold rise
Group 1Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.Serotype 23F (n= 85)34.01 Fold rise
Secondary

GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.

GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

Time frame: Pre-vaccination to 12 months after the last dose

Population: Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 19F (n= 80, 74, 109, 150)10.06 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 9V (n= 81, 76, 109, 162)12.73 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 23F (n= 79, 67, 97, 159)18.80 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 6B (n= 79, 58, 95, 161)25.52 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)10.19 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 110, 158)19.75 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 157)52.86 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 110, 158)45.07 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 19F (n= 80, 74, 109, 150)12.62 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 157)50.54 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 23F (n= 79, 67, 97, 159)13.50 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)55.55 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 9V (n= 81, 76, 109, 162)8.97 Fold rise
Group 2GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 6B (n= 79, 58, 95, 161)15.58 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 6B (n= 79, 58, 95, 161)7.99 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 9V (n= 81, 76, 109, 162)8.40 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)88.27 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 110, 158)41.14 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 19F (n= 80, 74, 109, 150)11.15 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 23F (n= 79, 67, 97, 159)11.39 Fold rise
Group 3GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 157)52.19 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 23F (n= 79, 67, 97, 159)2.86 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 18C (n= 81, 79, 110, 158)11.43 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 14 (n= 81, 79, 111, 162)15.67 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 6B (n= 79, 58, 95, 161)3.16 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 4 (n= 81, 79, 111, 157)21.01 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 19F (n= 80, 74, 109, 150)4.19 Fold rise
Group 4GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.Serotype 9V (n= 81, 76, 109, 162)3.35 Fold rise
Secondary

GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.

GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

Time frame: Pre-vaccination to 1 month after second dose of Prevenar in Group 2

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 4 (n= 87)705.95 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 6B (n= 63)16.64 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 9V (n= 84)44.72 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 14 (n= 87)217.21 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 18C (n= 87)317.90 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 19F (n= 85)33.66 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.Serotype 23F (n= 75)30.77 Fold rise
Secondary

GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.

GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.

Time frame: Pre-vaccination to 1 month after first dose of Prevenar in Group 3

Population: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 4 (n= 115)476.49 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 6B (n= 99)7.06 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 9V (n= 113)28.11 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 14 (n= 115)108.18 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 18C (n= 114)236.39 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 19F (n= 113)15.13 Fold rise
Group 1GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.Serotype 23F (n= 102)17.64 Fold rise

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026