A phase II, open-label, multicentre study to evaluate the safety and immunogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine as a booster dose in children aged 12 to 18 months, previously primed with the same vaccine in the primary vaccination study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). - DTPA-HBV-IPV=HIB-MENC-TT-004 BST: 002

Phase 1

• Conditions: Booster immunization of healthy children in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and serogroup C meningococcal (Men C) diseases.

• Registration Number: EUCTR2010-019253-18-PL
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-16
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
- A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. For corticosteroids, this will mean prednisone =0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
- Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
- Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002 (Pneumococcal vaccination is allowed in the MnC-CRM Group).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- The following adverse event having occurred after previous administration of DTP vaccine:
- Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
- Temperature of = 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting = 3 hours.
- Seizures with or without fever occurring within 3 days of vaccination.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be axillary.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified