Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00366899 |
Date of registration:
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17/08/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
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Scientific title:
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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 Paediatric Vaccinations in Italy |
Date of first enrolment:
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October 2006 |
Target sample size:
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605 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00366899 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Medical Monitor |
Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, descresg@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged 3 months (75 to 105 days) at time of enrollment.
2. Available for entire study period and whose parent(s)/legal guardian(s) could be
reached by telephone.
3. Healthy infant, as determined by medical history, physical examination, and judgment
of the investigator.
4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless
of gestational age and birth weight, all subjects must have met inclusion criterion
number 3.
5. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures
during study participation.
Exclusion criteria:
1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or
hepatitis B vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, or hepatitis B, or pneumococcal vaccines.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S pneumoniae or Hib.
8. Major known congenital malformation or serious chronic disorder.
9. 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. Did not include resolving syndromes due
to birth trauma such as Erb palsy.
10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies; eg, Synagis® [MedImmune]).
11. Participation in another investigational trial. Participation in purely observational
studies was acceptable.
12. Infant who was a direct descendant (eg, child or grandchild) of the study site
personnel.
Age minimum:
75 Days
Age maximum:
105 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vaccines, Pneumococcal
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Intervention(s)
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Biological: 13-valent pneumococcal conjugate vaccine
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Biological: 7 valent pneumococcal conjugate vaccine
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Primary Outcome(s)
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Percentage of Participants Reporting Pre-Specified Local Reactions
[Time Frame: During the 4-day period after each dose]
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Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
[Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]
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Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
[Time Frame: One month after the infant series (6 months of age) and the toddler dose (12 months of age)]
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Percentage of Participants Achieving an Antibody Level of =0.35 µg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
[Time Frame: one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)]
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Percentage of Participants Reporting Pre-Specified Systemic Events
[Time Frame: During the 4-day period after each dose]
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Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
[Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]
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Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
[Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]
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Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
[Time Frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]
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Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
[Time Frame: One month after the infant series (6 months of age) and after the toddler dose (12 months of age)]
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
[Time Frame: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)]
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Secondary Outcome(s)
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
[Time Frame: One month after toddler dose (12 months of age)]
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Percentage of Participants Achieving an Antibody Level of =0.35 µg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
[Time Frame: One month after the toddler dose (12 months of age)]
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Secondary ID(s)
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6096A1-500
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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