A PMS study to assess the safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib and INFANRIX HEXA™ vaccines when administered as a primary vaccination course, followed by admini-stration of GSK Biologicals’ DTPa-IPV/Hib vaccine as a booster dose in toddlers.

• Register: EUCTR
• Last refreshed on: 23 February 2015
• Main ID: EUCTR2012-002439-26-Outside-EU/EEA
• Date of registration: 17/02/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A PMS study to assess the safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib and INFANRIX HEXA™ vaccines when administered as a primary vaccination course, followed by admini-stration of GSK Biologicals’ DTPa-IPV/Hib vaccine as a booster dose in toddlers.
• Scientific title: An open, multicentre, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3 and 4 months of age and DTPa-HBV-IPV/Hib vaccine (INFANRIX HEXA™) administered at 5 months of age, as primary vaccination course, followed by administration of GSK Biologicals’ DTPa-IPV/Hib vaccine at 18 months of age in healthy infants who received hepatitis B vaccine at birth and at one month of age. - DTPa-HBV-IPV-100
• Target sample size: 702
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002439-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Singapore

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must have been enrolled in the Rota-028 study.
Subjects for whom the investigator believes that their par-ents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guard-ian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Subjects should have received two doses of hepatitis B vac-cine: at birth and at approximately one month of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 702
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:
Chronic administration of immunosuppressants or other immune-modifying drugs during the study period.
Planned administration/ administration of a vaccine not fore-seen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
Any confirmed or suspected immunosuppressive or immu-nodeficient condition, including human immunodeficiency virus infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness such as diar-rhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5 °C.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Primary immunization of healthy infants against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b diseases.

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: INFANRIX-IPV+HIB
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: NA
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: NA
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: NA
Other descriptive name: PERTUSSIS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: NA
Other descriptive name: FILAMENTOUS HAEMAGGLUTININ
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: NA
Other descriptive name: PERTUSSIS PERTACTIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: NA
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN)
Concentration unit: DAgU/ml D antigen unit(s)/millilitre
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: NA
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: NA
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 32-
INN or Proposed INN: NA
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: INFANRIX HEXA
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: NA
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: NA
Other d

Primary Outcome(s)

Main Objective: To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine.

Primary end point(s): Occurrence of solicited local and general adverse events.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: During the 4-day follow up period (Day 0 to Day 3) after vaccination.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For occurrence of unsolicited local and general adverse events: During the 30-day follow up period (Day 0 to Day 29) after vaccination.
For occurrence of large swelling reactions: After booster dose at Visit 4 (Month 15).
For occurrence of serious adverse events: During the entire study period (Day 0 to Month 21).

Secondary end point(s): Occurrence of unsolicited local and general adverse events.
Occurrence of large swelling reactions.
Occurrence of serious adverse events.

Secondary ID(s)

217744/100

Source(s) of Monetary Support

GlaxoSmithKline Biologicals