Last updated: 11/07/2018 07:49:45
Assessment of the serologic response to Porcine circovirus type 1 (PCV-1) in the serum of infants and toddlers, following administration of IPV (Inactivated poliovirus vaccine)-containing vaccines
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Blinded retrospective laboratory evaluations to assess the serologic response to Porcine circovirus type 1 (PCV-1) in the serum of infants aged 2 and 6 months and toddlers aged 4-6 years following administration of GlaxoSmithKline (GSK) Biologicals’ IPV-containing vaccines
Trial description: This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals’ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals’ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies [217744/085 and 213503/048] conducted in the United States.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Presence of serum anti-PCV-1 antibody.
Timeframe: At Day 0 and post vaccination time points (up to 1 month after vaccination).
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Dubin G et al. (2013) Investigation of a regulatory agency enquiry into potential porcine circovirus type 1 contamination of the human rotavirus vaccine, Rotarix™: approach and outcome. Hum Vaccin Immunother. 28;9(11). [Epub ahead of print].
Medical condition
Presence of materials from PCV-1
Product
SB217744
Collaborators
Not applicable
Study date(s)
May 2010 to May 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
2 months - 6 years
Accepts healthy volunteers
Yes
- Subjects enrolled previously in randomized, open and multicentre studies [217744/085; 213503/048].
- Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
- Subjects for whom sufficient residual volume of the pre and post vaccination blood samples is available.
Subjects enrolled previously in randomized, open and multicentre studies [217744/085; 213503/048].
Exclusion criteria:
- Not Applicable
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-25-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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