Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Streptococcal
Intervention: GSK1024850A (SynflorixTM) (Biological); Infanrix hexa (Biological); Infanrix-IPV/Hib (Biological); Ibuprofen (Drug); Paracetamol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The aim of the current study is to determine whether ibuprofen, given as immediate or
delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts
the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK)
Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined
vaccines, at 3, 4 and 5 months of age.
In addition, this study will further evaluate the impact of prophylactic administration of
paracetamol following primary vaccination with immediate or delayed administration or when
given in an immediate manner at the time of the booster dose.
Clinical Details
Official title: Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Evaluation of immune responses to components of the investigational vaccine
Secondary outcome: Occurrence of each solicited adverse event.Occurrence of unsolicited adverse events. Occurrence of serious adverse events Evaluation of immune responses to components of the investigational vaccine for additional parameters. Evaluation of immune responses to components of the co-administered DTPa-combined vaccines.
Eligibility
Minimum age: 12 Weeks.
Maximum age: 16 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable
Representative(s) (LAR) can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the
time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study
vaccines/products within 30 days preceding the first dose of study vaccine/product,
or planned use 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 (.
- Indication, other than specified in the protocol, for prophylactic or therapeutic
antipyretic treatment during the study period.
- Treatment with antipyretics in the 24 hours before study vaccination or planned
administration of antipyretics in the 24 hours after study vaccination.
- Chronic administration of immunosuppressants or other immune-modifying drugs since
birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol
during the period starting 30 days before each dose of study vaccine and ending 30
days after with the exception of locally recommended (pandemic) influenza vaccines,
and those should be documented in the eCRF.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of
the vaccines where the first dose may be given within the first two weeks of life
according to the national recommendations.
- History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B,
Haemophilus influenzae type b disease.
- History of any allergic disease or reaction likely to be exacerbated by any component
of the vaccines or prophylactic antipyretic treatment, i. e. ibuprofen or paracetamol,
as specified in the protocol.
- History of any seizures or progressive neurological disease.
- Acute disease and/or fever at the time of enrolment. The study entry should be
delayed until the illness has improved.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination .
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products since birth or planned
administration during entire study period.
- Any contraindication to treatment with ibuprofen as described in the ibuprofen
summary of product characteristics (SPC).
- Any contraindication to treatment with paracetamol as described in the paracetamol
SPC.
- Body weight < 5 kg at the time of enrolment.
- Child in care.
Locations and Contacts
GSK Investigational Site, Bacau 600316, Romania
GSK Investigational Site, Braila 810289, Romania
GSK Investigational Site, Braila 810346, Romania
GSK Investigational Site, Brasov 500063, Romania
GSK Investigational Site, Brasov 500260, Romania
GSK Investigational Site, Brasov 500366, Romania
GSK Investigational Site, Bucharest 051821, Romania
GSK Investigational Site, Bucharest 077190, Romania
GSK Investigational Site, Bucuresti 030442, Romania
GSK Investigational Site, Bucuresti 050734, Romania
GSK Investigational Site, Calarasi 910160, Romania
GSK Investigational Site, Cluj-Napoca 400217, Romania
GSK Investigational Site, Constanta 900709, Romania
GSK Investigational Site, Constanta 900721, Romania
GSK Investigational Site, Galati 800394, Romania
GSK Investigational Site, Galati 800099, Romania
GSK Investigational Site, Galati 800235, Romania
GSK Investigational Site, Galati 800322, Romania
GSK Investigational Site, Galati 800179, Romania
GSK Investigational Site, Iasi 700115, Romania
GSK Investigational Site, Pantelimon 77145, Romania
GSK Investigational Site, Sibiu 550166, Romania
GSK Investigational Site, Timisoara, Romania
Additional Information
Starting date: November 2010
Last updated: September 25, 2013
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