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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

Page last updated: August 20, 2015

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