Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
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|ClinicalTrials.gov Identifier: NCT00452452|
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : August 15, 2012
Last Update Posted : August 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Infections||Biological: 13-valent Pneumococcal Conjugate Vaccine||Phase 3|
|Study Type :||Interventional|
|Actual Enrollment :||355 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Biological: 13-valent Pneumococcal Conjugate Vaccine
- Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination [ Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). ]Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 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) are presented.
- Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups [ Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). ]GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented.
- Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ]Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ]Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452452
|Bydgoszcz, Poland, 85-168|
|Bydgoszcz, Poland, 85-316|
|Debica, Poland, 39-200|
|Krakow, Poland, 31-503|
|Leczna, Poland, 21-010|
|Lodz, Poland, 91-738|
|Oborniki Salskie, Poland, 55-120|
|Proznan, Poland, 61-709|
|Trzebnica, Poland, 55-100|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Principal Investigator:||Trial Manager||For Poland: WPWZMED@wyeth.com|