Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00444457
First received: March 5, 2007
Last updated: October 10, 2012
Last verified: October 2012
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Results First Received: June 11, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention |
| Condition: |
Vaccines, Pneumococcal |
| Interventions: |
Biological: 13-valent Pneumococcal Conjugate Vaccine Biological: 7vPnC |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 13vPnC (Pilot Lot 1) | Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| 13vPnC (Pilot Lot 2) | Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| 13vPnC (Manufacturing Lot) | Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| 7vPnC | Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
Participant Flow for 3 periods
Period 1: Infant Series
| 13vPnC (Pilot Lot 1) | 13vPnC (Pilot Lot 2) | 13vPnC (Manufacturing Lot) | 7vPnC | |
|---|---|---|---|---|
| STARTED | 489 | 488 | 489 | 246 |
| Vaccinated Dose 1 | 486 | 484 | 485 | 244 |
| Vaccinated Dose 2 | 455 | 447 | 455 | 228 |
| Vaccinated Dose 3 | 442 | 435 | 438 | 225 |
| COMPLETED | 435 | 427 | 428 | 218 |
| NOT COMPLETED | 54 | 61 | 61 | 28 |
| Unknown | 0 | 1 | 0 | 0 |
| Parent or legal guardian request | 18 | 29 | 34 | 14 |
| Lost to Follow-up | 10 | 11 | 7 | 6 |
| Protocol Violation | 16 | 8 | 6 | 3 |
| Failed to return | 5 | 4 | 4 | 2 |
| Investigator request | 4 | 3 | 3 | 2 |
| Unspecified | 0 | 2 | 4 | 0 |
| Adverse Event | 1 | 2 | 2 | 0 |
| Death | 0 | 1 | 1 | 1 |
Period 2: After Infant Series
| 13vPnC (Pilot Lot 1) | 13vPnC (Pilot Lot 2) | 13vPnC (Manufacturing Lot) | 7vPnC | |
|---|---|---|---|---|
| STARTED | 435 | 427 | 427 | 218 |
| COMPLETED | 415 [1] | 397 [1] | 408 [1] | 208 [1] |
| NOT COMPLETED | 20 | 30 | 19 | 10 |
| Unknown | 0 | 1 | 1 | 1 |
| Parent or legal guardian request | 4 | 11 | 6 | 3 |
| Failed to return | 7 | 6 | 5 | 1 |
| Lost to Follow-up | 5 | 5 | 5 | 2 |
| Protocol Violation | 2 | 4 | 2 | 2 |
| Adverse Event | 2 | 2 | 0 | 0 |
| Investigator request | 0 | 0 | 0 | 1 |
| Unspecified | 0 | 1 | 0 | 0 |
| [1] | Not completed=Withdrawn after infant series |
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Period 3: Toddler Dose
| 13vPnC (Pilot Lot 1) | 13vPnC (Pilot Lot 2) | 13vPnC (Manufacturing Lot) | 7vPnC | |
|---|---|---|---|---|
| STARTED | 415 [1] | 397 [1] | 408 [1] | 208 [1] |
| COMPLETED | 408 | 391 | 404 | 200 |
| NOT COMPLETED | 7 | 6 | 4 | 8 |
| Lost to Follow-up | 4 | 1 | 1 | 3 |
| Failed to return | 2 | 2 | 1 | 3 |
| Parent or legal guardian request | 0 | 3 | 2 | 1 |
| Protocol Violation | 1 | 0 | 0 | 1 |
| [1] | Vaccinated toddler dose |
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Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 13vPnC (Pilot Lot 1) | Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| 13vPnC (Pilot Lot 2) | Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| 13vPnC (Manufacturing Lot) | Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| 7vPnC | Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. |
| Total | Total of all reporting groups |
Baseline Measures
| 13vPnC (Pilot Lot 1) | 13vPnC (Pilot Lot 2) | 13vPnC (Manufacturing Lot) | 7vPnC | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
489 | 488 | 489 | 246 | 1712 |
|
Age
[units: months] Mean ± Standard Deviation |
2.2 ± 0.3 | 2.2 ± 0.3 | 2.2 ± 0.3 | 2.2 ± 0.3 | 2.2 ± 0.3 |
|
Gender, Customized
[units: participants] |
|||||
| Female | 230 | 226 | 213 | 115 | 784 |
| Male | 259 | 260 | 275 | 131 | 925 |
| Unknown | 0 | 2 | 1 | 0 | 3 |
Outcome Measures
| 1. Primary: | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series [ Time Frame: 1 Month after the infant series (7 Months of age) ] |
| 2. Primary: | Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ] |
| 3. Primary: | Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ] |
| 4. Primary: | Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ] |
| 5. Secondary: | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ] |
| 6. Secondary: | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] |
| 7. Secondary: | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ] |
| 8. Secondary: | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] |
| 9. Secondary: | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] |
| 10. Other Pre-specified: | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 7 days after dose (2 months of age) ] |
| 11. Other Pre-specified: | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 7 days after dose (4 months of age) ] |
| 12. Other Pre-specified: | Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 7 days after dose (6 months of age) ] |
| 13. Other Pre-specified: | Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) [ Time Frame: Within 7 days after dose (12 months of age) ] |
| 14. Other Pre-specified: | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 7 days after dose (2 months of age) ] |
| 15. Other Pre-specified: | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 7 days after dose (4 months of age) ] |
| 16. Other Pre-specified: | Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 7 days after dose (6 months of age) ] |
| 17. Other Pre-specified: | Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) [ Time Frame: Within 7 days after dose (12 months of age) ] |