Trial Outcomes & Findings for A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers (NCT NCT01298544)
NCT ID: NCT01298544
Last Updated: 2018-12-19
Results Overview
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) 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.
COMPLETED
PHASE4
335 participants
Day 1 (36 months after toddler dose)
2018-12-19
Participant Flow
All eligible participants who completed a previous study, 0887X-101518 (NCT00488826), were invited to participate in this study, at a timepoint at least 3 years after their last vaccination in study 0887X-101518.
No vaccines administered during study. However, participants assessed according to the vaccine group they were assigned to in study 0887X-101518: 7-valent pneumococcal conjugate vaccine (7vPnC) alone (Group 1), 7vPnC given concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) (Group 2), or DTaP alone (Group 3).
Participant milestones
| Measure |
Entire Study Population
All randomized participants
|
|---|---|
|
Overall Study
STARTED
|
335
|
|
Overall Study
COMPLETED
|
335
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=335 Participants
All randomized participants
|
|---|---|
|
Age, Continuous
|
5.04 years
STANDARD_DEVIATION 0.150 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (36 months after toddler dose)Population: Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) 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.
Outcome measures
| Measure |
7vPnC
n=123 Participants
No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
|
7vPnC and DTaP
n=121 Participants
No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
|
DTaP Alone
n=91 Participants
No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 4
|
0.98 microgram per milliliter (mcg/mL)
Interval 0.77 to 1.23
|
0.66 microgram per milliliter (mcg/mL)
Interval 0.52 to 0.84
|
0.41 microgram per milliliter (mcg/mL)
Interval 0.29 to 0.58
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 6B
|
11.35 microgram per milliliter (mcg/mL)
Interval 9.71 to 13.27
|
9.24 microgram per milliliter (mcg/mL)
Interval 7.66 to 11.16
|
3.37 microgram per milliliter (mcg/mL)
Interval 2.76 to 4.13
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 9V
|
1.35 microgram per milliliter (mcg/mL)
Interval 1.13 to 1.62
|
1.29 microgram per milliliter (mcg/mL)
Interval 1.08 to 1.54
|
1.05 microgram per milliliter (mcg/mL)
Interval 0.83 to 1.32
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 14
|
4.50 microgram per milliliter (mcg/mL)
Interval 3.38 to 5.98
|
3.02 microgram per milliliter (mcg/mL)
Interval 2.25 to 4.05
|
0.55 microgram per milliliter (mcg/mL)
Interval 0.4 to 0.76
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 18C
|
0.80 microgram per milliliter (mcg/mL)
Interval 0.66 to 0.97
|
0.77 microgram per milliliter (mcg/mL)
Interval 0.6 to 0.98
|
0.34 microgram per milliliter (mcg/mL)
Interval 0.24 to 0.47
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 19F
|
10.14 microgram per milliliter (mcg/mL)
Interval 8.06 to 12.75
|
5.67 microgram per milliliter (mcg/mL)
Interval 4.5 to 7.14
|
1.70 microgram per milliliter (mcg/mL)
Interval 1.35 to 2.15
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Serotype 23F
|
3.31 microgram per milliliter (mcg/mL)
Interval 2.8 to 3.91
|
2.71 microgram per milliliter (mcg/mL)
Interval 2.26 to 3.25
|
1.44 microgram per milliliter (mcg/mL)
Interval 1.17 to 1.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (36 months after toddler dose)Population: Evaluable Immunogenicity population
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.
Outcome measures
| Measure |
7vPnC
n=123 Participants
No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
|
7vPnC and DTaP
n=121 Participants
No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
|
DTaP Alone
n=91 Participants
No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
|
|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 4
|
82.9 Percentage of participants
Interval 75.1 to 89.1
|
64.5 Percentage of participants
Interval 55.2 to 73.0
|
48.8 Percentage of participants
Interval 37.7 to 60.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 6B
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
97.8 Percentage of participants
Interval 92.3 to 99.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 9V
|
93.5 Percentage of participants
Interval 87.6 to 97.2
|
94.2 Percentage of participants
Interval 88.4 to 97.6
|
83.5 Percentage of participants
Interval 74.3 to 90.5
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 14
|
95.1 Percentage of participants
Interval 89.7 to 98.2
|
91.7 Percentage of participants
Interval 85.3 to 96.0
|
63.7 Percentage of participants
Interval 53.0 to 73.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 18C
|
81.3 Percentage of participants
Interval 73.3 to 87.8
|
69.4 Percentage of participants
Interval 60.4 to 77.5
|
45.5 Percentage of participants
Interval 34.8 to 56.4
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 19F
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
97.5 Percentage of participants
Interval 92.9 to 99.5
|
92.2 Percentage of participants
Interval 84.6 to 96.8
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Serotype 23F
|
100.0 Percentage of participants
Interval 97.0 to 100.0
|
99.2 Percentage of participants
Interval 95.5 to 100.0
|
93.4 Percentage of participants
Interval 86.2 to 97.5
|
Adverse Events
Entire Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER