Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
NCT ID: NCT01235949
Last Updated: 2019-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
850 participants
INTERVENTIONAL
2010-11-12
2012-12-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Group IIBU
Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group DIBU
Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group NIBU
No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Group IPARA
Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group DPARA
Delayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group NPARA
No paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Group IIBU-IIBU
1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group IIBU-DIBU
1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Group IIBU-NIBU
1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group DIBU-IIBU
1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group DIBU-DIBU
1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group DIBU-NIBU
1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Group NIBU-IIBU
1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group NIBU-DIBU
1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group NIBU-NIBU
1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Group IPARA-NPARA
subjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Group DPARA-IPARA
subjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Group NPARA-IPARA
subjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination
GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Interventions
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GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Infanrix hexa
Intramuscular injection, 3 doses
Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Weeks
16 Weeks
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Bacau, , Romania
GSK Investigational Site
Brasov, , Romania
GSK Investigational Site
Brasov, , Romania
GSK Investigational Site
Brasov, , Romania
GSK Investigational Site
Brăila, , Romania
GSK Investigational Site
Brăila, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Călăraşi, , Romania
GSK Investigational Site
Cluj-Napoca, , Romania
GSK Investigational Site
Constanța, , Romania
GSK Investigational Site
Constanța, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Iași, , Romania
GSK Investigational Site
Pantelimon, , Romania
GSK Investigational Site
Sibiu, , Romania
GSK Investigational Site
Timișoara, , Romania
Countries
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References
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Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, Schnell CN, Sas V, Lupu VV, Francois N, Swinnen K, Borys D. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.
Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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2010-019761-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
112921
Identifier Type: -
Identifier Source: org_study_id
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