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Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.

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.

Author information

1
a Department of Pediatrics, Children's Clinic Hospital, Faculty of Medicine , Transilvania University , Brasov , Romania.
2
b Mother and Child Department , University of Medicine and Pharmacy "Iuliu Hatieganu ," Cluj-Napoca , Romania.
3
c Pediatric Clinic , Pediatric Clinic Hospital Sibiu , Sibiu , Romania.
4
d Medical Department , Lucian Blaga University of Sibiu , Sibiu , Romania.
5
e Preventive Medicine Department , Prophylaxis Center , Timisoara , Romania.
6
f Department of Pediatrics , Dunarea de Jos University of Galati , Galati , Romania.
7
g Saint Andrew Children Hospital Galati , Galati , Romania.
8
h General Practitioner , Private Practice , Galati , Romania.
9
i General Practitioner , Private Practice , Calarasi , Romania.
10
j Fundamental and Prophylactic Sciences Department , Transilvania University , Brasov , Romania.
11
k Department of Pediatrics , Grigore T. Popa University of Medicine and Pharmacy , Iasi , Romania.
12
l General Practitioner , Private Practice , Braila , Romania.
13
m Third Pediatric Clinic , Emergency Clinical Hospital for Children , Cluj-Napoca , Romania.
14
n GSK , Wavre , Belgium.
15
o XPE Pharma & Science for GSK , Wavre , Belgium.

Abstract

Prophylactic paracetamol administration impacts vaccine immune response; this study ( www.clinicaltrials.gov : NCT01235949) is the first to assess PHiD-CV immunogenicity following prophylactic ibuprofen administration. In this phase IV, multicenter, open-label, randomized, controlled, non-inferiority study in Romania (November 2010-December 2012), healthy infants were randomized 3:3:3:1:1:1 to prophylactically receive immediate, delayed or no ibuprofen (IIBU, DIBU, NIBU) or paracetamol (IPARA, DPARA, NPARA) after each of 3 primary doses (PHiD-CV at age 3/4/5 months co-administered with DTPa-HBV-IPV/Hib at 3/5 and DTPa-IPV/Hib at 4 months) or booster dose (PHiD-CV and DTPa-HBV-IPV/Hib; 12-15 months). Non-inferiority of immune response one month post-primary vaccination in terms of percentage of infants with anti-pneumococcal antibody concentrations ≥0.2 µg/mL (primary objective) was demonstrated if the upper limit (UL) of the 98.25% confidence interval of difference between groups (NIBU vs IIBU, NIBU vs DIBU) was <10% for ≥7/10 serotypes. Immunogenicity and reactogenicity/safety were evaluated, including confirmatory analysis of difference in fever incidences post-primary vaccination in IBU or DIBU group compared to NIBU. Of 850 infants randomized, 812 were included in the total vaccinated cohort. Non-inferiority was demonstrated for both comparisons (UL was <10% for 9/10 vaccine serotypes; exceptions: 6B [NIBU], 23F [IIBU]). However, fever incidence post-primary vaccination in the IIBU and DIBU groups did not indicate a statistically significant reduction. Prophylactic administration (immediate or delayed) of paracetamol decreased fever incidence but seemed to reduce immune response to PHiD-CV, except when given only at booster. Twenty-seven serious adverse events were reported for 15 children; all resolved and were not vaccination-related.

KEYWORDS:

10-valent pneumococcal conjugate; Ibuprofen; fever; paracetamol; prophylaxis; vaccine

PMID:
27541270
PMCID:
PMC5360152
DOI:
10.1080/21645515.2016.1223001
[Indexed for MEDLINE]
Free PMC Article

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