Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in 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:
NCT00368966
First received: August 25, 2006
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaccines, Pneumococcal |
Biological: 13-valent Pneumococcal Conjugate Vaccine Biological: 7-valent Pneumococcal Conjugate Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Phase 3, 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 Spain |
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 Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [ Time Frame: One month after 2-doses of the infant series (5 months of age) ] [ Designated as safety issue: No ]Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.
- Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [ Time Frame: One month after 2-doses of the infant series (5 months of age) ] [ Designated as safety issue: No ]
- Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [ Time Frame: One month after 2-doses of the infant series (5 months of age) ] [ Designated as safety issue: No ]
- Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (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 (Mod) (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 ] [ Designated as safety issue: Yes ]Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
- Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [ Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) ] [ Designated as safety issue: No ]GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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 Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.
- Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]
- Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]
- Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.
- Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [ Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) ] [ Designated as safety issue: No ]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, present in both 13vPnC and 7vPnC (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.
| Enrollment: | 619 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Biological: 13-valent Pneumococcal Conjugate Vaccine |
| Active Comparator: 2 | Biological: 7-valent Pneumococcal Conjugate Vaccine |
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
- Available for the entire study period
Exclusion criteria:
- Previous vaccination with any vaccine before the start of the study
- Known contraindication to vaccination
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368966
Locations
| Spain | |
| Ferrol, A Coruna, Spain, 15405 | |
| Santiago de Compostela, A Coruna, Spain, 15706 | |
| Argentona, Barcelona, Spain, 08310 | |
| Sabadell, Barcelona, Spain, 08208 | |
| Sant Adria de Besos, Barcelona, Spain, 08930 | |
| Sant Cugat del Valles, Barcelona, Spain, 08195 | |
| Sant Cugat del Valles, Barcelona, Spain, 08197 | |
| Bilbao, Bizkaia, Spain, 48013 | |
| Burela, Lugo, Spain, 27880 | |
| Alcorcon, Madrid, Spain, 28922 | |
| Fuenlabrada, Madrid, Spain, 28943 | |
| Getafe, Madrid, Spain, 28902 | |
| Getafe, Madrid, Spain, 28900 | |
| Mostoles, Madrid, Spain, 28937 | |
| Parla, Madrid, Spain, 28980 | |
| Antequera, Malaga, Spain, 29200 | |
| Pamplona, Navarra, Spain, 31008 | |
| Vigo, Pontevedra, Spain, 36204 | |
| Burjassot, Valencia, Spain, 46110 | |
| La Eliana, Valencia, Spain, 46183 | |
| Quart de Poblet, Valencia, Spain, 46930 | |
| A Coruna, Spain, 15006 | |
| Almeria, Spain, 04007 | |
| Almeria, Spain, 04120 | |
| Almeria, Spain, 04009 | |
| Barcelona, Spain, 08025 | |
| Barcelona, Spain, 08017 | |
| La Coruna, Spain, 15270 | |
| Madrid, Spain, 28021 | |
| Madrid, Spain, 28041 | |
| Malaga, Spain, 29015 | |
| Ourense, Spain, 32005 | |
| Sevilla, Spain, 41013 | |
| Valencia, Spain, 46200 | |
| Valencia, Spain, 46021 | |
| Valencia, Spain, 46011 | |
| Valencia, Spain, 46024 | |
| Valencia, Spain, 46013 | |
| Valencia, Spain, 46022 | |
| Valencia, Spain, 46008 | |
| Valencia, Spain, 46023 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
More 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: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00368966 History of Changes |
| Other Study ID Numbers: | 6096A1-501 |
| Study First Received: | August 25, 2006 |
| Results First Received: | March 26, 2010 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Pneumococcal Pediatric Vaccine |
ClinicalTrials.gov processed this record on May 21, 2013