In accordance with the recommendations of the National Immunization Schedule and the World Health Organization Act-HIB vaccine is used in combination with other vaccines administered simultaneously, e.g., DTP whole cell vaccine, or with acellular pertussis. In this regard, the safety profile of the drug Act-Hib corresponds to its combined use with other vaccines.
The adverse events presented below are listed according to the system organ class and frequency of occurrence. The frequency of occurrence is determined based on the following criteria: very common (≥1 / 10), often (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely <1/10000), the frequency is unknown (can not be estimated from available data).
Clinical Trials Data
In clinical studies with the active monitoring of adverse events was attended by about 7,000 healthy infants and children under 2 years of age who were vaccinated with the vaccine Act-Hib combined with DTP vaccine with whole cell or acellular pertussis component.
In controlled trials,when the Act-Hib vaccine was used concomitantly with the DPT vaccine, the frequency and type of subsequent systemic reactions did not differ from these values after vaccination with the DPT vaccine alone.
This section presents the undesirable phenomena possibly associated with the use of the Act-Hib vaccine, and more than 1% of participants observed after vaccination in clinical trials (that is, with frequency "often" and "very often"). All undesirable phenomena are grouped by frequency. Usually they appeared in the first 6-24 hours after vaccination and were transient and weak or of medium severity.
In subsequent injections of the vaccine, the frequency and severity of these adverse events did not increase as a result of the course of primary immunization.
The most frequent reactions after the introduction of the Act-Hib vaccine were reactions at the injection site, increased body temperature and irritability.
From the side of the psyche
Very often: irritability
Often or infrequently: prolonged or abnormal crying
From the gastrointestinal tract
Very often: vomiting
General disorders and disorders at the site of administration
Often: fever (≥ 38 ° C)
Infrequently: fever (≥ 39 ° C)
Soreness, redness, swelling, and / or inflammation, sealing at the injection site - from often to very often.
Post-registration data
Since spontaneous reports of adverse events in the commercial use of the drug were very rare and from a population with an undetermined number of patients, their frequency was classified as "frequency unknown."
Immune system disorders
Hypersensitivity reactions
Edema of the face, swelling of the larynx (suggesting a possible hypersensitivity reaction)
From the nervous system
Febrile or afconvulsions
From the respiratory system
Deeply preterm infants (born at 28 weeks or earlier) within 2-3 days after vaccination may experience cases of lengthening the time intervals between respiratory movements (see section "Special instructions").
From the skin and subcutaneous tissues
Hives, rash, itching
General disorders and disorders at the site of administration
Pronounced edema (≥ 5 cm) at the injection site, including swelling that spreads through one or both joints of one or both of the lower limbs (with a predominance of edema on the extremities to which the vaccine was administered).These reactions appeared 24-72 hours after the administration of the vaccine and could be accompanied by cyanosis, redness, increased skin temperature at the injection site, and severe crying. All the symptoms passed independently within 24 hours without any residual phenomena.