Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
NCT ID: NCT00384059
Last Updated: 2013-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
286 participants
INTERVENTIONAL
2006-10-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
13-valent pneumococcal vaccine
13-valent Pneumococcal Conjugate Vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
Pediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
NeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
Menitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
2
7-valent pneumococcal vaccine
7vPnC
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
Pediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
NeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
Menitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
Interventions
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13-valent Pneumococcal Conjugate Vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
7vPnC
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
Pediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
NeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
Menitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
Eligibility Criteria
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Inclusion Criteria
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. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion Criteria
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate 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, Neisseria meningitidis, 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. This 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®).
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.
42 Days
98 Days
ALL
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Atherstone, , United Kingdom
Bangor, , United Kingdom
Bristol, , United Kingdom
Co Antrim, , United Kingdom
Coventry, , United Kingdom
Ely, , United Kingdom
London, , United Kingdom
Oxford, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Weston-super-Mare, , United Kingdom
Countries
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References
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Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. doi: 10.1097/inf.0b013e3181faa6be.
Other Identifiers
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6096A1-007
Identifier Type: -
Identifier Source: org_study_id
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