Combination Vaccine Found Safe and Effective for Infants

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Combination Vaccine Found Safe and Effective for Infants

By Judith Groch, Senior Writer, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

October 04, 2007

ROCHESTER, N.Y., Oct. 4 -- A combination vaccine that adds hepatitis B and polio

virus to the standard DTP vaccine was found safe and just as immunogenic as the

customary five separate shots, according to a 22-center study.

Action Points

Explain to interested patients that the five-in-one combination vaccine -- DTP,

hepatitis B, and polio -- proved safe and effective when given with two other

separate influenza and pneumonia shots.

Explain that this reduced the number of immunizations from five (DTP, hepatitis

B, polio influenza, pneumonia) to three at each visit.

Point out that administration of combination vaccine appeared to be associated

with higher rates of irritability, transient fever>100.4°F (38.0°C) and some

local symptoms compared with separate vaccines.

The combination vaccine, Pediatrix (diphtheria, tetanus, pertussis [DTaP],

hepatitis B, and polio virus), approved in 2002, is made by GlaxoKline,

which supported this study and participated in its design and data collection.

Streamlining an infant's immunization schedule from a total of 15 shots over the

three checkups to nine shots will help promote parent compliance, timely

vaccination, and fewer administration errors, Pichichero, M.D., of the

University of Rochester, and colleagues, wrote in the Journal of Pediatrics.

The study overturns findings from a previous study that suggested problems when

two specific vaccines, recommended for two-, four-, and six-month checkups, were

given at the same time.

The vaccines concerned were Pediatrix (diphtheria, tetanus, pertussis [DTaP],

hepatitis B, and polio virus) and Prevnar, a pneumococcal 7-valent conjugate

vaccine (PCV-7).

Earlier studies had found that when the combination vaccine and the pneumonia

vaccine were given together, a suboptimal immune response was produced against

pertussis in the combination vaccine, along with more uncomfortable reactions,

such as fever and swelling at the injection site, Dr. Pichichero said.

The pneumonia vaccine, Prevnar (Lederle laboratories), was approved in 2000,

about two years before the combination vaccine, Pediatrix, was licensed.

A total of 575 healthy two-month-olds were enrolled at 22 sites nationwide. Each

infant was randomly assigned to one of three groups:

Combination vaccine, in which infants were given three vaccines, including

Pediatrix (DTaP, HepB, IPV), a second vaccine to protect against Haemophilus

influenzae type B (HiB), and a third, Prevnar for PCV-7.

Separate vaccines, in which infants received five independent vaccines including

DTaP, HepB, IPV for polio virus, HiB, and PVC-7.

Staggered vaccines, which was the same as the combination group, except that

PCV-7 was delayed by two weeks at every appointment, thereby requiring six

office visits, instead of three.

Blood samples were collected before the study began, and again at seven months.

Parents were given a diary and were asked to record temperatures, general

symptoms such as fussiness, or loss of appetite, and pain or swelling at the

injection site.

Immunogenicity in the combination vaccine group was noninferior to that of the

separate and staggered vaccine groups with seroprotective rates for diphtheria,

tetanus, and poliovirus and to geometric mean concentrations for pertussis, the

researchers said.

Seroprotective rates for HepB and Hib were not different between groups, and

seropositivity for PCV-7 was high in all groups.

Overall, irritability was the most frequently reported general symptom in all

the groups and was significantly higher for the combination vaccine infants.

Fever rates above 101.3 F were significantly higher in the combination vaccine

group. Fever lasted for only a day in all the groups.

Overall, medical advice was sought for fever after eight vaccine doses in eight

different infants, three in the combination group. However, no group differences

were observed in rates of symptoms for which parents sought medical advice.

Local reactions were significantly higher in the combination vaccine group

compared with the staggered vaccine group for pain or swelling. None of the

local symptoms at any injection site led to a medical visit.

Immunogenicity for the combined vaccine given along with HiB and PCV-7 vaccines

as a three-dose primary series was at least as good at that of the separately

administered vaccines with respect to DTaP, and polio-virus antibody response.

Furthermore, the researchers said, seroprotection rates for hepatitis B were

above 98% for all the groups.

Although inconsistent differences in the response to pertussis had been observed

in smaller clinical trials of PCV-7 given with the combination vaccine,

importantly, the immune response for all criteria, including whooping cough, was

similar to the separate and staggered groups, the researchers said.

This study put to rest earlier reservations by showing that the combined vaccine

is just as safe and effective as separate shots, and that concerns about

pertussis immunity have been dispelled, the researchers concluded.

The CDC's Advisory Committee on Immunization Practices, along with the American

Academy of Pediatrics, endorse the use of parenteral combination vaccines if

licensed and indicated for the patient's age, instead of their equivalent

component vaccines.

This study was supported by a grant from GlaxoKline Biologicals, Rixensart,

Belgium. Editorial support was provided by Scientific Therapeutics Information

of Springfield, N.J. The study design and collection of the data were by

GlaxoKline. All analyses were done at the University of Rochester except

for the analysis of the anti-Streptococcus pneumoniae antibody, which was done

at the GlaxoKline Laboratory in Rixensart, Belgium.

Interpretation of data, writing of the manuscript, and decision to submit the

paper for publication was made by the authors with contribution from

GlaxoKline. No form of payment was provided to any of the authors in

conjunction with development of this manuscript.

Dr. Pichichero reported that he has received research grants and/or honoraria

from GlaxoKline, Sanofi Pasteur Inc, Wyeth, and Merck for vaccine-related

research. Co-author Henry H. Bernstein, DO, has been a recipient of

grant/research funding from GlaxoKline. Mark M. Blatter, M.D., serves on

the Speakers' Bureaus for Sanofi Pasteur and GlaxoKline. He has received

grant/research funding from GlaxoKline, Sanofi Pasteur, Wyeth, Merck

MedImmune, and Chiron Lode Schuerman, M.D., is an employee of GlaxoKline

and has stock options at the company. Brigitte Cheuvart, Ph.D., is an employee

of GlaxoKline. J. Holmes, Ph.D., is a former employee of and

previous consultant for GlaxoKline.

Primary source: The Journal of Pediatrics

Source reference:

Pichichero ME, et al " Immunogenicity and Safety of a Combination Diphtheria,

Tetanus Toxoid, Acellular Pertussis, Hepatitis B, and Inactivated Poliovirus

Vaccine Coadministered with a 7-Valent Pneumococcal Conjugate Vaccine and a

Haemophilus Influenzae Type b Conjugate Vaccine " J Pediatr 2007; 151: 43-49.

http://www.medpagetoday.com/Pediatrics/Vaccines/dh/6881

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