Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine
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Purpose
The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix™ IPV or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life.
This protocol posting deals with objectives & outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The objectives & outcome measures of the primary phase & booster phase at 12 to 15 months are presented in a separate protocol posting (NCT number =00258700 ).
| Condition | Intervention | Phase |
|---|---|---|
|
Prophylaxis H. Influenzae Type b and Meningococcal Serogroup C Diseases |
Biological: Menitorix Biological: Infanrix IPV |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals' Hib & Meningococcal C Vaccine (Menitorix™) 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix™ at 2, 3, 4 Months of Age |
- SBA-MenC titre [ Time Frame: In all subjects of groups HibMenC and LicMenC at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2) ] [ Designated as safety issue: No ]
- Anti-PRP concentration [ Time Frame: In all subjects of groups HibMenC and LicMenC at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2) ] [ Designated as safety issue: No ]
- Anti-PSC concentration. [ Time Frame: In all subjects of groups HibMenC and LicMenC at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2) ] [ Designated as safety issue: No ]
- Anti-FHA concentration [ Time Frame: In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster) ] [ Designated as safety issue: No ]
- anti-PRN concentration [ Time Frame: In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster) ] [ Designated as safety issue: No ]
- anti-PT concentration [ Time Frame: In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster) ] [ Designated as safety issue: No ]
- All SAEs considered related to vaccination by the investigator in all subjects of groups HibMen and LicMenC. [ Time Frame: From last study contact of booster phase to end of this persistence study ] [ Designated as safety issue: No ]
- SAEs occurring after administration of to Infanrix™ IPV and Menitorix™ vaccines to UK subjects. [ Time Frame: Up to 30 days after vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 288 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group HibMenC
Previously primed in infancy with Hib-MenC and Infanrix-IPV and boosted with Hib-MenC (Priorix co-administered). All UK subjects will received a booster dose of Infanrix IPV at 40 to 43 months of age.
|
Biological: Infanrix IPV
Infanrix IPV will be administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
|
|
Active Comparator: Group LicMenC
Previously primed in infancy with Meningitec and Pediacel and boosted with Hib-MenC (Priorix co-administered). All UK subjects will received a booster dose of Infanrix IPV at 40 to 43 months of age.
|
Biological: Infanrix IPV
Infanrix IPV will be administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
|
|
Active Comparator: Group NoBoost
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects will received a booster dose of Infanrix IPV and Menitorix at 40 to 43 months of age.
|
Biological: Menitorix
Menitorix will only be administered to subjects of the group NoBoost at 40 to 43 months of age.
Biological: Infanrix IPV
Infanrix IPV will be administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
|
Detailed Description:
This multicentre & multicountry study is open and has 2 study groups at Visits 1 and 3 (HibMenC and LicMenC). An additional control group in the UK at the time of the second year follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be further randomized. The subjects of group NoBoost will not be randomized. All subjects at the UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix™ booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a Hib catch-up vaccine (Menitorix™) at the same visit.
Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses: at 12, 24 & 48 months after the booster vaccination. Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects will be enrolled in this study (group NoBoost).
Eligibility| Ages Eligible for Study: | 24 Months to 64 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having completed the booster vaccination study 104056.
Subjects of group NoBoost at Visit 2 (UK only):
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between and including 40 and 43 months of age at Visit 2.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.
Exclusion Criteria:
- Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056.
- History of H. influenzae type b or meningococcal diseases.
- For UK subjects of groups HibMenC and LicMenC only: previous administration of a booster dose of a pertussis-containing vaccine except booster study vaccines during the study 104056.
Contacts and Locations| Poland | |
| GSK Investigational Site | |
| Bydgoszcz, Poland, 85-021 | |
| GSK Investigational Site | |
| Gdansk, Poland, 80-394 | |
| GSK Investigational Site | |
| Kielce, Poland, 25-711 | |
| GSK Investigational Site | |
| Leczna, Poland, 21-010 | |
| GSK Investigational Site | |
| Poznan, Poland, 6-709 | |
| GSK Investigational Site | |
| Siemianowice Slaskie, Poland, 41-103 | |
| GSK Investigational Site | |
| Trzebnica, Poland, 55-100 | |
| United Kingdom | |
| GSK Investigational Site | |
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00454987 History of Changes |
| Other Study ID Numbers: | 109664, 109666, 109668 |
| Study First Received: | March 30, 2007 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
antibody persistence Meningococcal serogroup C vaccine conjugate vaccine Haemophilus influenzae type b vaccine |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013