Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX(TM) and placebo versus PedvaxHIB(TM) and RECOMBIVAX HB(TM) in healthy infants

Vaccination News Home Page

http://www.elsevier.com/gej-ng/10/42/35/80/47/30/abstract.html

Please note! As of 2002 online access to full-text articles is available to all readers whose library
  1. subscribes to Vaccine via ScienceDirect or
  2. has a print subscription to Vaccine and has registered for the corresponding ScienceDirect Web Editions.


Vaccine, Vol. 21 (3-4) (2002) pp. 181-187
© 2002 Elsevier Science Ltd. All rights reserved.
PII: S0264-410X(02)00469-3
 

Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX(TM) and placebo versus PedvaxHIB(TM) and RECOMBIVAX HB(TM) in healthy infants

Karen M. Kaplan a * karen_kaplan@merck.com , Steven A. Rusche a, Hassan D. Lakkis a, Gerald Bottenfield b, Fernando A. Guerra c, Juan Guerrero d, Harry Keyserling e, Elise Felicione a, Teresa M. Hesley a and John W. Boslego a

a Merck & Co. Inc., P.O. Box 4, BL 1-7, West Point, PA 19486, USA
b R/D Clinical Research, Lake Jackson, TX, USA
c San Antonio Metropolitan Health District, San Antonio, TX, USA
d Austin Diagnostic Clinic-Radiant Research, Austin, TX, USA
e Emory University School of Medicine, Atlanta, GA, USA

Received 23 July 2002; received in revised form 6 September 2002; accepted 10 September 2002

Abstract

Background: In a previous clinical trial comparing COMVAX(TM) with its monovalent components, PedvaxHIB(TM) and RECOMBIVAX HB(TM), one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX(TM) compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit.

Objectives: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX(TM) plus placebo and recipients of PedvaxHIB(TM) plus RECOMBIVAX HB(TM) following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit.

Design: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6-7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection.

Results: Reports of unusual, high-pitched crying and prolonged crying were uncommon (<1%) prior to the first vaccination visit and were comparable in both treatment groups. After each injection, rates of unusual, high-pitched crying (range: 4.26-6.96%) and prolonged crying (range: 0-1.36%) appeared similar between treatment groups and for each vaccination visit. Crying resolved in all infants; no neurological impairment was reported.

Conclusion: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX(TM) plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB(TM) and RECOMBIVAX HB(TM).

Keywords: Unusual high-pitched crying; Prolonged crying; Vaccine safety

*Corresponding author. Tel.: +1-484-344-3414; fax: +1-215-616-2388.

Full text supplied by [ScienceDirect]

© Copyright 2002, Elsevier Science, All rights reserved.

Vaccination News Home Page

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.