Related Experiment Video

Updated: Feb 12, 2026

Author Spotlight: Advancements and Challenges in Surgical Treatments for Postamputation Pain

Author Spotlight: Advancements and Challenges in Surgical Treatments for Postamputation Pain

Published on: March 8, 2024

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants:

Jose Manuel Merino Arribas¹, Alfonso Carmona Martínez², Michael Horn³

¹From the Pediatric Department, Hospital Universitario de Burgos, Burgos, Spain.

The Pediatric Infectious Disease Journal

|April 6, 2018

Insights

Coadministering the diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine and 10-valent pneumococcal conjugate vaccine (PHiD-CV) with the quadrivalent meningococcal conjugate vaccine (MenACWY-TT) in infants demonstrated strong immunogenicity. The combined vaccination schedule showed acceptable safety and reactogenicity profiles.

Area of Science:

Pediatric Vaccinology
Immunology
Public Health

Background:

Evaluating the immunogenicity and safety of combined childhood vaccines is crucial for optimizing immunization schedules.
The study focuses on a novel coadministration strategy involving DTPa-HBV-IPV/Hib, PHiD-CV, and MenACWY-TT vaccines.

Purpose of the Study:

To assess the immunogenicity and reactogenicity of coadministering DTPa-HBV-IPV/Hib and PHiD-CV with MenACWY-TT in infants and toddlers.
To determine the safety profile of this combined vaccination regimen.

Main Methods:

A phase III, open, controlled study randomized 2095 healthy infants into four groups.
Participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4, and 12 months, with varying meningococcal vaccine schedules.
Immunogenicity and reactogenicity were evaluated at multiple time points post-vaccination.

Main Results:

High seropositive/seroprotective rates were achieved for DTPa-HBV-IPV/Hib antigens (≥97.2% postprimary, ≥97.9% postbooster).
Infants showed robust antibody responses to PHiD-CV, with ≥74.0% achieving protective levels postprimary vaccination.
The most frequent solicited local symptom was redness at injection sites, observed in up to 57.0% of doses.

Conclusions:

Coadministration of DTPa-HBV-IPV/Hib and PHiD-CV with MenACWY-TT is immunogenic in infants/toddlers.
The combined vaccination regimen exhibits clinically acceptable reactogenicity.
These findings support the coadministration of MenACWY-TT with routine childhood vaccines.

Read full analysis

Abstract

Background:

This study evaluated the immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and a 10-valent pneumococcal conjugate vaccine (PHiD-CV) coadministered with a quadrivalent meningococcal conjugate vaccine (MenACWY-TT) in infants/toddlers.

Methods:

In this open, controlled, phase III study (NCT01144663), 2095 healthy infants were randomized (1:1:1:1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age or MenACWY-TT, MenC-CRM197, or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immunogenicity of DTPa-HBV-IPV/Hib was evaluated in exclusive randomized subsets of 25% of participants from each group postprimary, prebooster and postbooster vaccination, whereas immunogenicity of PHiD-CV was evaluated at all time points. Reactogenicity was evaluated on the total vaccinated cohorts during 8 days after each vaccination.

Results:

For each DTPa-HBV-IPV/Hib antigen, ≥97.2%, ≥76.5% and ≥97.9% of participants had seropositive/seroprotective levels 1 month postprimary vaccination, before the booster dose and 1 month postbooster, respectively. For each vaccine pneumococcal serotype, ≥74.0% of infants had antibody concentrations ≥0.35 μg/mL at 1 month postprimary vaccination, and robust increases in antibody geometric mean concentrations were observed from prebooster to postbooster. Redness was the most frequent solicited local symptom at the DTPa-HBV-IPV/Hib and PHiD-CV injection sites, reported after up to 47.7% and 57.0% of doses postprimary and postbooster vaccination, respectively.

Conclusions:

Primary and booster vaccinations of infants/toddlers with DTPa-HBV-IPV/Hib and PHiD-CV coadministered with MenACWY-TT were immunogenic with clinically acceptable reactogenicity profiles. These results support the coadministration of MenACWY-TT with routine childhood vaccines.

More Related Videos

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Published on: April 19, 2024

Author Spotlight: Regenerative Peripheral Nerve Interface (RPNI) Surgery in Postamputation Pain Management

Author Spotlight: Regenerative Peripheral Nerve Interface (RPNI) Surgery in Postamputation Pain Management

Published on: March 15, 2024

Related Concept Videos

Trial and Error and Algorithm

Trial and Error and Algorithm

A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

Random Error

Random Error

Random or indeterminate errors originate from various uncontrollable variables, such as variations in environmental conditions, instrument imperfections, or the inherent variability of the phenomena being measured. Usually, these errors cannot be predicted, estimated, or characterized because their direction and magnitude often vary in magnitude and direction even during consecutive measurements. As a result, they are difficult to eliminate. However, the aggregate effect of these errors can be...

Random Variables

Random Variables

A random variable is a single numerical value that indicates the outcome of a procedure. The concept of random variables is fundamental to the probability theory and was introduced by a Russian mathematician, Pafnuty Chebyshev, in the mid-nineteenth century.
Uppercase letters such as X or Y denote a random variable. Lowercase letters like x or y denote the value of a random variable. If X is a random variable, then X is written in words, and x is given as a number.
For example, let X = the...

Randomized Experiments

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...

Articles linked to this work by shared authors, journal, and citation graph.

Adjuvanted RSVPreF3 vaccine impact over three respiratory syncytial virus seasons in older adults with comorbidities.

ERJ open research·2026

Singing and Calling Behavior of a Threatened Passerine With Spatially Variable Vocalizations: Individual, Population and Geographic Patterns.

Ecology and evolution·2026

New diagnostic techniques included in the primary care service portfolio of the Spanish public health system.

Anales de pediatria·2026

Value of lumbar puncture in identifying secondary causes of visual snow syndrome: A case-control study.

Cephalalgia : an international journal of headache·2026

Synthesis and Reactions of Hydrazine Trifluoroborate Salts.

Organic letters·2026

Immunogenicity and safety of co-administration of AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine and a COVID-19 mRNA vaccine in adults aged ≥50 years: a phase 3, randomized, non-inferiority trial.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2026

See all related articles