Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00464945
First received: April 23, 2007
Last updated: July 6, 2012
Last verified: July 2012

April 23, 2007
July 6, 2012
June 2007
September 2008   (final data collection date for primary outcome measure)
  • Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (5 months of age) ] [ Designated as safety issue: No ]
    Percentages of participants achieving 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.
  • 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 reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema 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 (Infant Series) [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]
    Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) [ Time Frame: During the 4-day period after toddler dose ] [ Designated as safety issue: Yes ]
    Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
  • Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (5 months of age) ] [ Designated as safety issue: No ]
    Antibody concentration/geometric mean concentration (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.
To compare immunogenicity of manufacturing scale 13vPnC to pilot scale 13vPnC using serotype specific serum IgG antibody levels, to assess safety by local injection site reactions and systemic events, and adverse events.
Complete list of historical versions of study NCT00464945 on ClinicalTrials.gov Archive Site
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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Vaccines
Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
  • Experimental: 1
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Aged 2 months (42 to 98 days) at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
  3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. Known or suspected immune deficiency or suppression.
  6. History of culture-proven invasive disease caused by S pneumoniae.
  7. Major known congenital malformation or serious chronic disorders.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
  9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Both
41 Days to 99 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00464945
6096A1-3000
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP