A randomized study to evaluate the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae B, and meningococcal serogroup C combination vaccine administered to infants at 2, 4 and 12 months of age
Thollot F.,Association Francaise de pediatrie Ambulatoire |
Scheifele D.,Vaccine Evaluation Center |
Pankow-Culot H.,Pediatric Office |
Cheuvart B.,Glaxo SmithKline Vaccines |
And 3 more authors.
Pediatric Infectious Disease Journal | Year: 2014
Background: The immunogenicity and safety of the investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine were compared with those of licensed control vaccines. Methods: In this open, phase II, randomized study (NCT01090453), 480 infants from Germany, France and Canada received the heptavalent vaccine (Hepta group) or hexavalent and monovalent MenC control vaccines (HexaMenC group) co-administered with a 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age. Immunogenicity was measured 1 month after the second primary dose, and before and 1 month after the booster dose. Safety and reactogenicity were also evaluated. Results: Non-inferiority of immune responses to MenC and Hib induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated. In exploratory analyses, postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower (1119.5 vs. 3200.5; 2653.8 vs. 6028.4) and antibody geometric mean concentrations against Hib higher (1.594 vs. 0.671 μg/mL; 17.678 vs. 13.737 μg/mL) in the Hepta versus the HexaMenC group. The heptavalent and control vaccines were immunogenic to all other antigens, although immune responses to poliovirus were lower than expected in both groups. No differences in safety and reactogenicity profiles were detected between groups. Conclusions: The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines. Both vaccination regimens, when administered at 2, 4 and 12 months of age, had comparable safety profiles and were immunogenic to all antigens, with lower-than-expected responses to poliomyelitis. Copyright © 2014 by Lippincott Williams and Wilkins. Source
Molnar T.,University of Szeged |
Farkas K.,University of Szeged |
Nagy F.,University of Szeged |
Lakatos P.L.,Semmelweis University |
And 5 more authors.
Scandinavian Journal of Gastroenterology | Year: 2010
Objective. There is limited data on pregnancy outcome in inflammatory bowel diseases (IBD) (Crohn's disease [CD] and ulcerative colitis [UC]) from Eastern Europe. The aim of our multicenter study was to compare the pregnancy outcomes and the data of infants in pregnancies before and after the diagnosis of IBD. Patients and methods. 97 pregnancies in women with IBD (36 CD and 61 UC) and 70 pregnancies in the same women before the diagnosis of IBD (24 CD and 46 UC) were compared. The influence of disease activity and medical treatment during pregnancy on gestational age at birth, birth weight, health status of the newborns and the frequency of childhood diseases were analyzed. Results. Preterm birth and low birth weight were more common in IBD compared to those pregnancies delivered before the diagnosis of the disease (p 0.008, p 0.048). The occurrence of congenital abnormalities was not influenced by IBD, whereas childhood diseases occurred more frequently in the offspring of mothers with active UC. Disease activity in CD and UC during pregnancy did not predispose to abnormal birth outcome, compared to inactive disease. The type of medical treatment did not affect the pregnancy outcome in IBD. Conclusion. Preterm birth and low birth weight were more common in IBD. The medical treatment of the active disease during pregnancy did not increase the frequency of abnormal birth outcomes. Medical maintenance treatment should be continued during pregnancy to avoid relapses, although IBD seems to be an independent risk factor for low birth weight and preterm birth. © 2010 Informa Healthcare. Source
Domachowske J.B.,Syracuse University |
Pankow-Culot H.,Pediatric Office |
Bautista M.,University of the East Ramon Magsaysay |
Feng Y.,Glaxosmithkline |
And 4 more authors.
Journal of Infectious Diseases | Year: 2013
Background. Two antigenically distinct influenza B lineages have cocirculated since 2001, yet trivalent influenza vaccines (TIVs) contain 1 influenza B antigen, meaning lineage mismatch with the vaccine is frequent. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages vs TIV in healthy children aged 3-17 years.Methods. Children were randomized 1:1:1 to receive QIV or 1 of 2 TIVs (either B/Victoria or B/Yamagata lineage; N = 2738). Hemagglutination-inhibition assays were performed 28 days after 1 or 2 doses in primed and unprimed children, respectively. Immunological noninferiority of QIV vs TIV against shared strains, and superiority against alternate-lineage B strains was based on geometric mean titers (GMTs) and seroconversion rates. Reactogenicity and safety were also assessed (Clinicaltrials.gov NCT01196988).Results. Noninferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV vs TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.Conclusions. QIV vs TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines. © 2013 The Author. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. Source
Knuf M.,Johannes Gutenberg University Mainz |
Pankow-Culot H.,Pediatric Office |
Grunert D.,Praxis Inc. |
Rapp M.,Pediatric Practice |
And 7 more authors.
Pediatric Infectious Disease Journal | Year: 2012
Background: Induction of immunologic memory was assessed following primary vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Methods: Infants were randomized (1:1) to receive 3 doses of PHiD-CV or 7vCRM (7-valent CRM197-conjugated pneumococcal conjugate vaccine [PCV]) at 2, 3, and 4 months of age followed by 23-valent pneumococcal polysaccharide vaccine (23vPS) booster dose at 11 to 14 months of age. Pneumococcal geometric mean antibody concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers were measured. Results: Postprimary immune responses were consistent with those in previous PHiD-CV and 7vCRM studies. Following 23vPS boosting, vaccine serotype-specific antibody GMCs increased 6.5-to 33.3-fold and 4.8-to 32.2-fold versus prebooster in the PHiD-CV and 7vCRM groups, respectively. Postbooster OPA titers increased 2.8-to 38.8-fold and 2.6-to 58.9-fold, respectively. Postbooster antibody GMCs exceeded postprimary levels but, for some serotypes, postbooster OPA geometric mean titers were lower than postprimary in both groups. An additional dose of the same PCV received for priming was administered to 52 children aged 46 to 50 months, resulting in higher responses versus postprimary vaccination for all serotypes, but not always higher than post-23vPS booster. Conclusions: Induction of immunologic memory following PHiD-CV priming was confirmed. Additional PCV boosting in 4-year-olds did not provide strong evidence of hyporesponsiveness induced by previous 23vPS boosting. However, our results did not rule out depletion of the memory B cell pool following 23vPS vaccination, resulting in subsequent attenuated immune responses, and therefore support the use of PCV rather than 23vPS for booster vaccination in the second year of life. © 2012 Lippincott Williams & Wilkins. Source
Rumke H.C.,Rotterdam University |
Loch H.P.,Medical Practice Wolfenbuttel |
Hoppenbrouwers K.,Catholic University of Leuven |
Vandermeulen C.,Catholic University of Leuven |
And 4 more authors.
Vaccine | Year: 2011
Background: The MMRV combination vaccine, Priorix-Tetra™, is currently licensed in several European countries using a two-dose schedule in infants aged ≥9 months, with a preferred 6-week to 3-month interval between doses. This study was undertaken to generate safety and immunogenicity data for two doses of MMRV vaccine administered according to dose schedules using the shortest permitted interval of 4 weeks versus a longer interval of 12 months, which would allow flexible adaptation to local immunization calendars. Methods: Healthy children aged 11-13 months were randomized (1:1:1) to receive 2 doses of either: MMRV vaccine with a 4-week interval between doses (MMRV-4W group, N= 188), MMRV vaccine with a 12-month interval between doses (MMRV-12M group, N= 184), or MMR vaccine with a 4-week interval between doses (MMR group, N= 187). Blood samples were taken prior to, and 4-6 weeks after each vaccination. Results: Post-Dose 2, both MMRV groups exhibited an adequate immunogenic response for all components; however the MMRV-12M group showed significantly greater geometric mean titers for mumps, rubella and varicella. Two varicella breakthrough cases occurred within the 12-month interval between doses in theMMRV-12Mgroup. Local and general reactogenicity results were similar for all groups except for the MMRV-4W group, which had a greater incidence of fever during Days 0-14 post-Dose 1. Conclusions: Two doses of MMRV vaccine administered in the second year of life elicited adequate immunogenicity and were well-tolerated whether administered with a dose interval of 4 weeks or 12 months. © 2011. Source