Phase 3
N=750
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00496015 ↗Enrolled (actual)
750
Serious AEs
8.7%
Results posted
Jan 2019
Primary outcome: Primary: Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off — 64; 14; 100; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pneumococcal conjugate vaccine GSK1024850A. (Biological); Infanrix hexa. (Biological); Meningococcal vaccine GSK134612. (Biological); Paracetamol. (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off |
64; 14; 100; 16; 146 | — |
| SECONDARY Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off |
4; 0; 14; 1; 16 | — |
| SECONDARY Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms. |
54; 10; 79; 19; 114; 2 | — |
| SECONDARY Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms |
91; 11; 84; 18; 146; 0 | — |
| SECONDARY Number of Subjects Reported With Unsolicited Adverse Events (AEs) |
22; 3; 64; 30 | — |
| SECONDARY Number of Subjects Reported With Serious Adverse Events (SAEs) |
13; 5; 13; 4; 30 | — |
| SECONDARY Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits. |
7; 1; 0; 53 | — |
| SECONDARY Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off |
74; 14; 115; 27; 6; 140 | — |
| SECONDARY Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off. |
0.22; 0.18; 0.31; 0.26; 0.03; 1.67 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
6.1; 5.6; 8.1; 6; 4.9; 144.6 | — |
| SECONDARY Concentrations of Antibodies Against Protein D (Anti-PD) |
365.1; 356.5; 685.5; 584.3; 65.6; 1654 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) |
0.12; 0.08; 0.21; 0.19; 0.03; 0.4 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
72.4; 35.6; 65.4; 66; 9.7; 251.5 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values |
69; 44; 298; 298; 136; 134 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group |
11.5; 2151.3; 677.6; 6.9; 811.2; 191.1 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values |
12; 1; 271; 271; 133; 47 | — |
| SECONDARY Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations |
0.16; 36.28; 0.99; 0.15; 14.12; 0.42 | — |
| SECONDARY Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group |
0.512 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group |
1336.1 | — |
| SECONDARY Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T). |
10.112; 9.839; 12.285; 11; 7.291; 7.382 | — |
| SECONDARY Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations |
83.3; 81.6; 82; 76.7; 163.1; 467.9 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations |
219.3; 147.3; 231.2; 139.2; 535.1 | — |
| SECONDARY Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations |
23.066; 26.006; 27.373; 22.011; 20.985 | — |
| SECONDARY Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers |
1193; 1534.2; 1058.7; 1208.6; 4096; 1354.1 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations |
219.3; 147.3; 231.2; 139.2; 535.1 | — |
| SECONDARY Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers |
208.2; 150.4; 234.5; 220.8; 335.4; 311.2 | — |
| SECONDARY Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes) |
43; 53; 45; 47; 49; 55 | — |
| SECONDARY Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes) |
13; 15; 19; 22; 21; 27 | — |
| SECONDARY Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) |
26; 27; 30; 42; 32; 45 | — |
| SECONDARY Number of Nasopharyngeal Swabs With H. Influenzae |
41; 48; 39; 56; 34; 62 | — |
| SECONDARY Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae |
19; 21; 20; 30; 17; 31 | — |
| SECONDARY Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs |
43; 56; 63; 76; 70; 73 | — |
| SECONDARY Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs. |
21; 32; 22; 40; 37; 42 | — |
Summary
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612).
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 12-15 months of age at the time of the 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 unprimed group
- A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A.
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
- 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 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.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines.
- 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 (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- Acute disease at the time of enrolment.
- 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 within three months preceding administration of the dose of study vaccines or planned administration during the study period.
- Subjects of which both parents have a history of atopia.
- 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:
- Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
- Encephalopathy.
- As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.
For subjects in the AP-AP, AP-NAP and NAP groups:
- Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017.
For subjects in the AP-AP group:
- Subject with any contraindication to treatment with paracetamol.
For subjects in the unprimed group:
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
- Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end.
- Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six m
Data sourced from ClinicalTrials.gov (NCT00496015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.