A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age - DTPA-IPV=HIB-MENC-TT-001 PRI

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-003741-87-GB
• Date of registration: 27/04/2009
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age - DTPA-IPV=HIB-MENC-TT-001 PRI
• Scientific title: A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age - DTPA-IPV=HIB-MENC-TT-001 PRI
• Date of first enrolment: 02/04/2009
• Target sample size: 280
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003741-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
All subjects must satisfy the following criteria at study entry:
•A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
• Born after 36 to 42 weeks of gestation.
• Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• 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.
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:
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, 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 or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
• History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• Current febrile illness or axillary temperature >=37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration.


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

Health Condition(s) or Problem(s) studied

Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b (Hib), serogroup C meningococcal and Streptococcus pneumoniae diseases. Booster immunisation of healthy one-year-old children against Hib and serogroup C meningococcal diseases

Intervention(s)

Product Name: DTPa-IPV/Hib-MenC-TT vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified diphtheria toxoid (D)
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Purified tetanus toxoid (T)
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: Purified pertussis toxoid (PT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Purified filamentous haemagglutinin (FHA)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Purified pertactin (PRN)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: Inactivated poliovirus types 1-2-3
Concentration unit: AgU antigen unit(s)
Concentration type: equal
Concentration number: 40-8-32-D-antigen units
INN or Proposed INN: Haemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Neisseria meningitidis serogroup C polysaccharide (PSC) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Menitorix
Product Name: Menitorix
Product Code: Hib-MenC-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Haemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Neisseria meningitidis serogroup C polysaccharide (PSC) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Menjugate
Product Name: Menjugate
Pharmaceutical Form: Powder and solven

Primary Outcome(s)

Secondary Objective: • To demonstrate that DTPa-IPV/Hib-MenC-TT given with Prevenar is non-inferior to Pediacel given with Prevenar & Menjugate, in terms of immune response to diphtheria, tetanus and poliovirus type 1, 2 and 3, one month after the 3rd primary dose. (Criteria for non-inferiority: upper limit of 95% CI on the difference (Control minus MenC-Combo group) in % of subjects with anti-D and anti-T concentrations >=0.1 IU/ml and with anti-poliovirus type 1, 2 and 3 titres >= 8 is <=10%)
To assess:
• Immune response to study vaccines (seroprotection/ seropositivity, GMCs/GMTs for all antigens at 1 month after the 3rd dose) and to DTPa-IPV/Hib-MenC-TT (seropositivity, GMC/GMT for MenC antigen at 1 month after 2nd dose).
• Safety/reactogenicity of DTPa-IPV/Hib-MenC-TT given with Prevenar.
• Persistence of antibodies to all antigens (seroprotection/ seropositivity and GMCs/ GMTs) before Menitorix booster.
• Safety/reactogenicity of Menitorix booster and immune response at 1 month after booster.

Main Objective: •To demonstrate that GSK Biologicals’ DTPa IPV/Hib-MenC-TT vaccine co-administered with Prevenar (MenC-Combo group) is non-inferior to Pediacel co-administered with Prevenar and Menjugate (Control group), in terms of immune response to Hib and MenC, one month after the third dose of primary vaccination.
Criteria for non-inferiority:
Non-inferiority in terms of response to PRP will be demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference (Control minus MenC-Combo group) in percentage of subjects with anti-PRP concentrations >= 0.15 micrograms/ml is <=10%.
Non-inferiority in terms of response to MenC will be demonstrated if the upper limit of the 95% CI on the group difference (Control minus MenC-Combo group) in percentage of subjects with SBA-MenC titres >= 8 is <=10%.

Primary end point(s): Immunogenicity one month after the third dose of study vaccines
• Seroprotection status: anti-PRP >= 0.15 µg/ml
• Seropositivity status: rSBA-MenC >= 8
(Proposed, non-validated cut-off for seroprotection)

Secondary ID(s)

111709