Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00689351
First received: May 29, 2008
Last updated: June 24, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Vaccine |
Biological: 13-valent pneumococcal conjugate vaccine Biological: 7-valent pneumococcal conjugate vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ] [ Designated as safety issue: No ]Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).
Secondary Outcome Measures:
- Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.
| Enrollment: | 180 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
13vPnC
|
Biological: 13-valent pneumococcal conjugate vaccine
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
|
|
Active Comparator: 2
7vPnC
|
Biological: 7-valent pneumococcal conjugate vaccine
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
|
Eligibility| Ages Eligible for Study: | 42 Days to 98 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy 2-month-old-infants (42 to 98 days)
- Available for the entire study period (14 months)
Exclusion Criteria:
- Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
- A previous severe reaction to any vaccine or vaccine-related component
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689351
Locations
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Incheon, Bupyeong-gu, Korea, Republic of, 400-711 | |
| Pfizer Investigational Site | |
| Seoul, Jongno-gu, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Incheon, Jung-gu, Korea, Republic of, 400-711 | |
| Pfizer Investigational Site | |
| Kyunggi, Koyang, Korea, Republic of, 412-270 | |
| Pfizer Investigational Site | |
| Seoul, Seodaemun-gu, Korea, Republic of, 120-752 | |
| Pfizer Investigational Site | |
| Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-950 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trial Disclosure Group, Wyeth, Inc |
| ClinicalTrials.gov Identifier: | NCT00689351 History of Changes |
| Other Study ID Numbers: | 6096A1-010, B1851001 |
| Study First Received: | May 29, 2008 |
| Results First Received: | December 10, 2010 |
| Last Updated: | June 24, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Prevention against pneumococcal disease Vaccine |
ClinicalTrials.gov processed this record on May 23, 2013