Abstract
ABSTRACTProphylactic 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.
Highlights
Pneumococcal conjugate vaccines (PCVs) provide protection against invasive pneumococcal disease (IPD) and other diseases such as acute otitis media or pneumonia;[1,2,3,4] PCVs have been included in many national childhood immunization programs
This study aimed to demonstrate non-inferiority of the immune response to PHiD-CV administered as a 3-dose primary course with immediate (IIBU) or delayed (DIBU) versus no prophylactic ibuprofen (NIBU) administration, in terms of percentage of infants with anti-pneumococcal antibody concentrations 0.2 mg/mL
Of 850 participants randomized, 812 were included in the total vaccination cohort (TVC) for primary vaccination and 768 in the TVC for booster vaccination (Fig. 1); 647 (79.7%) children from the primary and 575 (74.9%) children from the booster epoch were included in the according-to-protocol (ATP) cohort for immunogenicity
Summary
Pneumococcal conjugate vaccines (PCVs) provide protection against invasive pneumococcal disease (IPD) and other diseases such as acute otitis media or pneumonia;[1,2,3,4] PCVs have been included in many national childhood immunization programs. Co-administration of PCVs with standard infant vaccines was shown to induce a higher incidence of fever in children compared to single-vaccine administration.[5,6,7] Antipyretics, most commonly paracetamol and ibuprofen, are sometimes administered prophylactically to prevent fever during pediatric immunization.[8] prophylactic paracetamol administration significantly decreases febrile reactions, it has been shown to reduce immune responses to some vaccine antigens.[9] Prophylactic paracetamol administration Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/khvi. Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/khvi. # Contributed to this work
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