A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine. - 10PN-PD-DIT-014 BST:010

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001481-17-CZ
• Date of registration: 09/03/2007
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine. - 10PN-PD-DIT-014 BST:010
• Scientific title: A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine. - 10PN-PD-DIT-014 BST:010
• Date of first enrolment: 22/05/2007
• Target sample size: 860
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001481-17
• 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: no Placebo: no Other: no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
All subjects must satisfy the following criteria at study entry:
•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.
•A male or female between, and including, 12-15 months of age at the time of the booster vaccination.
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Subjects in the primed antipyretic and primed non-antipyretic group:
•A male or female who previously participated in study 10PN-PD-DIT-010 and received three doses of pneumococcal conjugate vaccine.

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:
For all subjects:
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).
Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month (30 days) preceding the dose of study vaccines, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines. (For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month (30 days) before the dose of study vaccines (Visit 1) and up to one month after the dose of study vaccines (Visit 2).
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products within three months preceding dose of study vaccines or planned administration during the study period.
Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
The following conditions are temporary or self-limiting and a subject may be included in the study and/or vaccinated once the condition has resolved and no other exclusion criteria are met:
Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.
DTPa-HBV-IPV/Hib vaccine
The following adverse events constitute absolute contraindications to administration of DTPa-HBV-IPV/Hib; if any of these adverse events occur during the study, the investigator must decide which vaccine to give to the subject for these antigens.
Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
Encephalopathy, defined as an acute, severe central nervous system disorder occurring within 7 days following pertussis 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.
As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.
N.B. Contraindication to the administratio

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

Health Condition(s) or Problem(s) studied

A single dose booster vaccination against Streptococcus pneumoniae of healthy children between 12-15 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate pneumococcal vaccine in the primary vaccination study 10PN-PD-DIT-010 and a first single dose vaccination against meningococcal disease due to serogroups A, C, W-135, or Y, of pneumococcal vaccine unprimed healthy children of 12-15 months of age.

Intervention(s)

Product Name: 10 valent streptococcus pneumoniae conjugate vaccine
Product Code: 10Pn-PD-DiT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PS-PS for serotypes 1,4,5,6B,7F,9V,14,23F; PS-TT for 18C and PS-DT for 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32,PD:24;TT:14-DT:9

Trade Name: Infanrix Hexa
Product Name: Infanrix Hexa
Product Code: DTPa-HBV-IPV / Hib
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Diphtheria toxoid
Current Sponsor code: D
Other descriptive name: detoxified diphteria toxin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: not less then
Concentration number: 60-
INN or Proposed INN: Tetanus toxoid
Current Sponsor code: T
Other descriptive name: detoxified tetanus toxin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: not less then
Concentration number: 80-
INN or Proposed INN: Bordetella pertussis antigens: pertussis toxoid (PT), filamentous haemagglutinin(FHA), Pertactin(PRN)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PT:50; FHA:50-PRN:16
INN or Proposed INN: Poliovirus inactivated (types 1,2,3)
Concentration type: equal
Concentration number: 1:80DU/ml;2:16-DU/ml;3:64DU/ml
INN or Proposed INN: Haemophilus type B polysaccharide (Hib) conjugated to Tetanux toxoid (TT)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: Hib:20-TT:40-80
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Panadol 125 mg
Product Name: Panadol 125
Pharmaceutical Form: Suppository
INN or Proposed INN: Paracetamol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Product Name: MenACWY conjugate vaccine
Product Code: MenACWY-TT
Pharmaceuti

Primary Outcome(s)

Main Objective: To determine the percentage reduction in febrile reactions (rectal temperature >=38.0°C or oral/axillary/tympanic >=37.5°C) when prophylactic antipyretic treatment is administered compared to no prophylactic antipyretic treatment, after booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine and routine DTPa-HBV-IPV/Hib (Infanrix hexa) vaccination in children at 12-15 months of age.

Primary end point(s): •Occurrence of core fever >=38°C(rectal temperature) within 4 days (days 0 to 3) after the administration of the vaccine dose in subjects of the primed group.

Secondary Objective: Safety of booster dose of 10-valent pneumococ conj vaccine and co-adm DTPa-HBV-IPV/Hib with/without prophylactic antipyretic treatment at 12-15 months of age
7 to 10 months post dose 3 of primary vaccination and prior to booster dose persistence of antibodies induced by 10-valent pneumococ conj vaccine
1 month post-booster immunogenicity of 10-valent pneumococ conj vaccine
12 to 15 months after booster dose persistence of antibodies induced by 10-valent pneumococ conj vaccine
Impact of 10-valent pneumococcal conj. vaccine on reducing the nasopharyngeal carriage of S. pneumoniae (vaccine serotypes+others) and H. influenzae
One month post vaccine dose immunogenicity of all antigens included in MenACWY-TT conj vaccine and in co-adm DTPa-HBV-IPV/Hib
12 to 15 months post vaccine dose, persistence of meningococ A, C, W, Y antibodies induced by MenACWY-TT conj vaccine and persistence of hep B and polio antibodies induced by co-adm DTPa-HBV-IPV/Hib
Safety of MenACWY-TT conj vaccine

Secondary ID(s)

107137