Pneumococcal Disease
Conditions
Keywords
Vaccine, Prevenar, Pneumococcal disease
Brief summary
In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.
Interventions
PROCEDUREBlood draw
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects who participated in and completed Wyeth study 0887X 101518. * Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion criteria
* Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518. * History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518. * Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Day 1 (36 months after toddler dose) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Day 1 (36 months after toddler dose) | 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. |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population All randomized participants | 335 |
| Total | 335 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 5.04 years STANDARD_DEVIATION 0.15 |
| Sex: Female, Male Female | 149 Participants |
| Sex: Female, Male Male | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 335 |
| serious Total, serious adverse events | 0 / 335 |
Outcome results
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC | 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) |
| 7vPnC | 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) |
| 7vPnC | 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) |
| 7vPnC | 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) |
| 7vPnC | 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) |
| 7vPnC | 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) |
| 7vPnC | 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) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 14 | 3.02 microgram per milliliter (mcg/mL) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 4 | 0.66 microgram per milliliter (mcg/mL) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 6B | 9.24 microgram per milliliter (mcg/mL) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 9V | 1.29 microgram per milliliter (mcg/mL) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 18C | 0.77 microgram per milliliter (mcg/mL) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 19F | 5.67 microgram per milliliter (mcg/mL) |
| 7vPnC and DTaP | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 23F | 2.71 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 18C | 0.34 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 6B | 3.37 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 23F | 1.44 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 19F | 1.70 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 14 | 0.55 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 9V | 1.05 microgram per milliliter (mcg/mL) |
| DTaP Alone | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Serotype 4 | 0.41 microgram per milliliter (mcg/mL) |
Comparison: Serotype 9V95% CI: [0.74, 1.23]
Comparison: Serotype 1495% CI: [0.45, 1.01]
Comparison: Serotype 18C95% CI: [0.7, 1.31]
Comparison: Serotype 495% CI: [0.48, 0.94]
Comparison: Serotype 6B95% CI: [0.64, 1.04]
Comparison: Serotype 19F95% CI: [0.4, 0.77]
Comparison: Serotype 23F95% CI: [0.64, 1.05]
Comparison: Serotype 495% CI: [1.39, 2.8]
Comparison: Serotype 6B95% CI: [2.41, 3.84]
Comparison: Serotype 9V95% CI: [0.98, 1.62]
Comparison: Serotype 1495% CI: [4.53, 9.79]
Comparison: Serotype 18C95% CI: [1.68, 3.24]
Comparison: Serotype 19F95% CI: [3.29, 6.07]
Comparison: Serotype 23F95% CI: [1.65, 2.63]
Other Pre-specified
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
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.
Time frame: Day 1 (36 months after toddler dose)
Population: Evaluable Immunogenicity population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC | 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 |
| 7vPnC | 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 |
| 7vPnC | 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 |
| 7vPnC | 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 |
| 7vPnC | 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 |
| 7vPnC | 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 |
| 7vPnC | 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 |
| 7vPnC and DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 14 | 91.7 Percentage of participants |
| 7vPnC and DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 4 | 64.5 Percentage of participants |
| 7vPnC and DTaP | 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 |
| 7vPnC and DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 9V | 94.2 Percentage of participants |
| 7vPnC and DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 18C | 69.4 Percentage of participants |
| 7vPnC and DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 19F | 97.5 Percentage of participants |
| 7vPnC and DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 23F | 99.2 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 18C | 45.5 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 6B | 97.8 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 23F | 93.4 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 19F | 92.2 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 14 | 63.7 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 9V | 83.5 Percentage of participants |
| DTaP Alone | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Serotype 4 | 48.8 Percentage of participants |
Comparison: Serotype 495% CI: [-29.4, -7.3]
Comparison: Serotype 6B95% CI: [-3.1, 3]
Comparison: Serotype 9V95% CI: [-5.9, 7.3]
Comparison: Serotype 1495% CI: [-10.3, 3.1]
Comparison: Serotype 18C95% CI: [-22.7, -1]
Comparison: Serotype 19F95% CI: [-7.1, 0.6]
Comparison: Serotype 23F95% CI: [-4.5, 2.3]
Comparison: Serotype 495% CI: [12.7, 37]
Comparison: Serotype 6B95% CI: [-0.011, 7.715]
Comparison: Serotype 9V95% CI: [1.9, 19.6]
Comparison: Serotype 1495% CI: [19.4, 40.5]
Comparison: Serotype 18C95% CI: [17.9, 41.5]
Comparison: Serotype 19F95% CI: [1.2, 13.9]
Comparison: Serotype 23F95% CI: [1.8, 13]