Last updated: 11/15/2018 22:10:12
A Phase III, randomized, single blind study to assess the immune response induced by Prevenar™(Wyeth Lederle) when administered to healthy infants with DTPa-HBV-IPV/Hib, compared to an investigational vaccination regimen as a 3-dose primary vaccination course at a monthly interval starting at 8–16 Weeks of age
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase III, randomized, single blind study to assess the immune response induced by Prevenar™(Wyeth Lederle) when administered to healthy infants with DTPa-HBV-IPV/Hib, compared to an investigational vaccination regimen as a 3-dose primary vaccination course at a monthly interval starting at 8–16 Weeks of age
Trial description: A Phase III, randomized, single blind study to assess the immune response induced by Prevenar™(Wyeth Lederle) when administered to healthy infants with DTPa-HBV-IPV/Hib, compared to an investigational vaccination regimen as a 3-dose primary vaccination course at a monthly interval starting at 8–16 Weeks of age
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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Medical condition
acellular pertussis, Diphtheria, Hepatitis B, Tetanus, Poliomyelitis, Haemophilus influenzae type b
Product
Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine
Collaborators
Not applicable
Study date(s)
October 2000 to November 2001
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-27-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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